Orphan drugs

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Orphan drugs is drugs used to treat rare diseases; not normally produced because potential sales are small

List of FDA orphan drugs

# Generic Name Orphan Designation Designation Date Designation Status
1 ((1r, 4r)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido4,5-bindol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate)-Expanded cord blood Prevention of Graft-versus-Host-Disease 12/13/2018 Designated
2 ((4-(3-benzyl-4-hydroxybenzyl)-3,5-dimethylphenoxy)methyl)phosphonic acid Treatment of X-linked adrenoleukodystrophy 12/05/2016 Designated
3 [[(+)-(2S)-2-(4-chloro-2-methoxyphenyl)-2-{3-methoxy-5-(methylsulfonyl)phenylamino}-1-5-(trifluoromethoxy)-1H-indol-3-ylethanone]] Treatment of dengue virus infection 12/26/2017 Designated
4 (+)-a-dihydrotetrabenazine Treatment pediatric patients with Tourette's syndrome 03/30/2017 Designated
5 (+)-alpha-dihydrotetrabenazine Treatment of Huntington's disease. 12/05/2018 Designated
6 (+)-Epicatechin Treatment of Duchenne and Becker muscular dystrophy 04/06/2020 Designated
7 (+/-)-7-3-(4-acetyl-3-methoxy-2-propylphenoxy)propoxy-3,4-dihydro-8-propyl-2H-1-benzopyran-2-carboxylic acid Prevention of serious adverse events associated with vascular leak syndrome caused by Interleukin-2 therapy 03/31/2003 Designated/Withdrawn
8 (+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-dihydro-2H-cromen-7-ol Treatment of cholangiocarcinoma 01/10/2008 Designated/Withdrawn
9 (+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-dihydro-2H-cromen-7-ol Treatment of pancreatic cancer 01/10/2008 Designated/Withdrawn
10 (+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-dihydro-2H-cromen-7-ol Treatment of Stage IIB through Stage IV malignant melanoma 02/01/2008 Designated/Withdrawn
11 (-)-(3aR,4S,7aR)-4-Hydroxy-4-m-tolylethynyl-octahydro-indole-1-carboxylic acid methyl ester Treatment of Fragile X syndrome 10/12/2011 Designated
12 (-)-huperzine A Treatment of Lennox-Gastaut Syndrome 06/15/2020 Designated
13 (1'R,6'R)-3-(Benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-1,1'-bi(cyclohexane)-2',3,6-triene-2,5-dione Treatment of systemic scleroderma (SSc) 07/06/2017 Designated
14 (1,3)-ß-D-glucan synthesis inhibitor Treatment of invasive Aspergillus infections 08/22/2016 Designated
15 (1-hydroxy-2-oxopiperidin-3-yl)phosphonic acid Treatment of Glioblastoma 08/09/2018 Designated
16 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-broethyl) diamidophosphate Treatment of pancreatic cancer 06/05/2013 Designated
17 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate Treatment of soft tissue sarcoma 03/09/2012 Designated
18 [[(1-{2-(3S,4R)-1-(3R,4R)-1-cyclopentyl-3-fluoro-4-(4-methoxyphenyl)pyrrolidine-3-carbonyl-4-(methoxymethyl)pyrrolidin-3-yl-5-(trifluoromethyl)phenyl}piperidine-4-caroxylic acid-phosphoric acid (1/1)]] treatment of cutaneous variants of porphyria (which includes treatment and prevention of cutaneous manifestations of disease) 06/08/2020 Designated
19 (13E,14E,22R,6R)-35-fluoro-6-methyl-7-aza-1(5,3)-pyrazolo1,5-apyrimidina-3(3,2)-pyridina-2(1,2)-pyrrolidinacyclooctaphan-8-one Treatment of solid tumors with neurotrophic tyrosine receptor kinase (NTRK)-fusion proteins 09/24/2018 Designated
20 (1E,6E)-1,7-Bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione and (1E,4Z,6E)-4-(cyclobutylmethyl)-1,7-bis(3,4-dimethoxyphenyl)-5-hydroxyhepta-1,4,6-trien-3-one Treatment of spinocerebellar ataxia 09/24/2019 Designated
21 (1E,6E)-1,7-Bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione and (1E,4Z,6E)-4-(cyclobutylmethyl)-1,7-bis(3,4-dimethoxyphenyl)-5-hydroxyhepta-1,4,6-trien-3-one Treatment of glioblastoma 08/23/2019 Designated
22 (1E,6E)-1,7-Bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione OR (1E,4Z,6E)-4-(cyclobutylmethyl)-1,7-bis(3,4-dimethoxyphenyl)-5-hydroxyhepta-1,4,6-trien-3-one Treatment of Huntington’s Disease 05/14/2019 Designated
23 (1R,2R)-1,2-cyclohexane-diaminepyrophosphato-platinum(II) Treatment of multiple myeloma 11/22/2017 Designated
24 (1R,2R)-1,2-cyclohexane-diaminepyrophosphato-platinum(II) Treatment of thymoma and thymic carcinoma 10/25/2018 Designated
25 (1R,3R,4R,5S)-3-O-2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate- Treatment of vaso-occlusive crisis in patients with sickle cell disease. 02/17/2009 Designated
26 (1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol-hydrochloride Treatment of acute lymphoblastic leukemia 08/13/2004 Designated
27 (1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol-hydrochloride Treatment of T-cell non-Hodgkin's lymphoma 01/29/2004 Designated
28 (1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol-hydrochloride Treatment of chronic lymphocytic leukemia and related leukemias to include prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia 08/10/2004 Designated
29 (1S)-6-chloro-1,3,4,9-tetrahydro-1-(4-methoxyphenyl)-2H-pyrido3,4-bindole-2-carboxylic acid, 4-chlorophenyl ester Treatment of Acute myeloid leukemia 01/27/2020 Designated
30 (1S, 2S, 3R, 4R)-3-(5-Fluoro-2-(3-methyl-4-(4-methylpiperazin-1-yl)-phenylamino)-pyrimidin-4-ylamino)bicycle2.2.1hept-5-ene-2-carboxamide benzoate Treatment of acute myeloid leukemia 01/19/2010 Designated/Withdrawn
31 (1S, 4R, 5R, 7S)-3, 4-dibenzyl-2-oxo-6, 8-dioxa- 3-azabyciclo 3.2.1 octane-7-carboxylic acid-L-lysine Treatment of Neurotrophic keratopathy 11/30/2018 Designated
32 (1S,3S)-3-((2-methyl-6-(1-methyl-5-(((methyl(propyl)carbamoyl)oxy)methyl)-1H-1,2,3-triazol-4-yl)pyridin-3-yl)oxy)cyclohexane-1-carboxylic acid Treatment of Idiopathic Pulmonary Fibrosis 12/17/2018 Designated
33 (1S,3S)-3-amino-4-(difluoromethylene)cyclopentanecarboxylic acid hydrochloride, (1S,3S)-3-amino-4-difluoromethylenyl-1-cyclopentanoic acid hydrochloride Treatment of infantile spasms 09/15/2010 Designated
34 (2'R,3'S)-2'-hydroxy-N-carboxy-3'-amino-5'-methyl-hexanoic,N-tert-butyl ester, 13 ester 5B-20-epoxy-1B,2a,4a,7B,9a,10a,13a-heptahydroxy-4,10-diacetate-2-benzoate-(1"S)-7,9-acrolein acetal-11(15-1)-abeotaxane Treatment of progressive supranuclear palsy 06/23/2014 Designated
35 (2,2-diphenyl-tetrahydro-furan-3-yl-methyl)-dimethylamine hydrochloride Treatment of Rett Syndrome. 05/18/2016 Designated
36 (2-((2-chlorophenyl)(phenyl)amino)-N-(7-(hydroxyamino)-7-oxoheptyl)pyrimidine-5-carboxamide) Treatment of multiple myeloma 11/29/2016 Designated
37 (2-(2-chlorophenyl)-4-3-(dimethylamino)phenyl-5-methyl-1h-pyrazolo 4,3-c pyridine-3,6(2h,5h)-dione) Treatment of systemic sclerosis. 10/14/2015 Designated
38 (2-(3-(4-(1H-indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt) Treatment of graft versus host disease (GVHD) 10/05/2017 Designated
39 (20S)-7-tert-butyldimethysilyl-10-hydroxycamptothecin Treatment of glioblastoma multiforme (GBM) 07/13/2017 Designated
40 (2R,3S)-2-(3-(4,5-dichloro-1H-benzodimidazol-1-yl)propyl)piperidin-3-ol Hydrogen Chloride Treatment of idiopathic pulmonary fibrosis 08/05/2019 Designated
41 (2R,4R)-1-(3-chloro-2-fluorobenzyl)-4-((3-fluoro-6-((5-methyl-1H-pyrazol-3-yl)amino)pyridin-2-yl)methyl)-2-methylpiperidine-4-carboxylic acid; 2- methylpropan-2-amine Treatment of Neuroblastoma 01/29/2020 Designated
42 [[(2S)-2-{(2R)-2-({3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yloxy}acetyl)amino-2-(4-hydroxyphenyl)acetylamino}butanoic acid]] Treatment of progressive familial intrahepatic cholestasis 10/31/2012 Designated
43 [[(2S)-2-{(2R)-2-({3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yloxy}acetyl)amino-2-(4-hydroxyphenyl)acetylamino}butanoic acid]] Treatment of primary biliary cirrhosis 10/31/2012 Designated
44 [[(2S)-2-{(2R)-2-({3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yloxy}acetyl)amino-2-(4-hydroxyphenyl)acetylamino}butanoic acid]] Treatment of Alagille syndrome 10/15/2018 Designated
45 (2S)-N-(1S)-1-cyclohexyl-2-(2S)-2-4-(4-fluorobenzoyl)-1,3-thiazol-2-ylpyrrolidin-1-yl-2-oxoethyl-2-(methylamino)propanamide Treatment of multiple myeloma 06/28/2017 Designated
46 (2S,3R,4R,5S)-2-(hydroxymethyl)-1-pentylpiperidine-3,4,5-triol Treatment of GM2 gangliosidosis 08/01/2019 Designated
47 (2S,3S,4E,6S,7R,10R)-7,10-Dihydroxy-3,7-dimethyl-12-oxo-2-(2E,4E,6R)-6-(pyridin-2-yl)hepta-2,4-dien-2-yloxacyclododec-4-en-6-yl 4-methylpiperazine-1-carboxylate Treatment of acute myeloid leukemia (AML) 06/21/2017 Designated
48 (2S,3S,4E,6S,7R,10R)-7,10-Dihydroxy-3,7-dimethyl-12-oxo-2-(2E,4E,6R)-6-(pyridin-2-yl)hepta-2,4-dien-2-yloxacyclododec-4-en-6-yl 4-methylpiperazine-1-carboxylate Treatment of chronic myelomonocytic leukemia (CMML) 06/22/2017 Designated
49 (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4-fluoropyrrolidine-2-carboxamide Treatment of paroxysmal nocturnal hemoglobinuria 11/02/2017 Designated
50 (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4-fluoropyrrolidine-2-carboxamide Treatment of C3 glomerulopathy (C3G) 12/14/2017 Designated
51 (2Z)-2-cyano-3-3hydroxy-N-4-(trifluoromethly)phenyl-2-hepten-6-ynamide Prevention of acute rejection following kidney, heart, and liver transplantation 01/10/2005 Designated
52 (3,5-Bis trifluoromethyl)-N-4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl benzamide Treatment of pancreatic cancer 03/18/2011 Designated
53 (3,5-Bis trifluoromethyl)-N-4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl benzamide Treatment of chronic myelogenous leukemia. 03/18/2011 Designated
54 (3,5-Bis trifluoromethyl)-N-4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl benzamideNRC-AN-019 Treatment of Glioma 03/18/2011 Designated
55 (3E,5E)-3,5-bis(4-fluoro-3-nitrophenyl)methylidene-1-(prop-2-enoyl)azepan-4-0ne Treatment of multiple myeloma 04/30/2014 Designated
56 [[(3R)-3-Methyl-6-2-({5-methyl-2-4-(trifluoromethyl)phenyl-1H-imidazol-1-yl}methyl)phenoxyhexanoic acid hemisulfate]] Treatment of Duchenne muscular dystrophy 03/28/2018 Designated
57 (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno4,5-bfuran-2(9bH)-one fumarate Treatment of glioblastoma multiforme 11/08/2017 Designated
58 (3S)-(+)-(5-chloro-2-methoxyphenyl)-1,3-dihydro-3-fluoro-6-(trifluoromethyl)-2H-indol-2-one Treatment of Fragile X Syndrome. 12/09/2015 Designated
59 [[(3S)-3-(2S)-2-({N-2-tert-butyl)phenylcarbamoyl}carbonylamino) propanoylamino-4-oxo-5-(2,3,5,6-tetrafluorophenoxy) pentanoci acid]] Treatment of patients undergoing solid organ transplantation. 08/19/2003 Designated
60 [[(3S)-3-({1-(2-Chlorobenzyl)-4-hydroxy-5-methyl-2-oxo-1,2-dihydropyridin-3yl}amino)carbonylamino-3-(4-methylphenyl)propanoic acid monosodium salt]] For mobilization of hematopoietic stem cells 04/25/2016 Designated
61 (3S,4R)-3-ethyl-4-(3H-imidazo1,2-apyrrolo2,3-epyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate Treatment of Pediatric Crohn's disease 06/15/2017 Designated
62 (4R,5R)-1-4-4-3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-ylphenoxymethylphenylmethyl-4-aza-l-azoniabicyclo2.2.2octane Chloride Treatment of primary sclerosing cholangitis 09/04/2013 Designated
63 (4R,5R)-1-4-4-3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-ylphenoxymethylphenylmethyl-4-aza-l-azoniabicyclo2.2.2octane Chloride Treatment of primary biliary cirrhosis 09/04/2013 Designated
64 (4R,5R)-1-4-4-3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-ylphenoxymethylphenylmethyl-4-aza-l-azoniabicyclo2.2.2octane Chloride Treatment of alagille syndrome 09/04/2013 Designated
65 (4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1-H-pyrano3?,4?:6,7-indolizino-1,2-b-quinoline-11-carbaldehyde O-(tert-butyl)-(E)-oxime Treatment malignant glioma 11/29/2002 Designated/Withdrawn
66 [[(5R)-5-(4-{(2-fluorophenyl)methyloxy}phenyl)-L-prolinamide, hydrochloride]] Treatment of erythromelalgia 01/30/2017 Designated
67 (5S,8S, 10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo1,2-a1,5 diazocine-8-carboxyamide Treatment of ovarian cancer 04/14/2016 Designated
68 (6-(4-((4-(1H-pyrazol-4-yl)phenyl)amino)pyrimidin-2-yl)-1-methyl-1H-indol-2-yl)(3,3-difluoroazetidin-1-yl)methanone Treatment of Idiopathic Pulmonary Fibrosis 05/08/2019 Designated
69 (6-4-Deoxy-4-(2E,4E)-tetradecadienoylglycyl amino-L-glyceroB-L-manno-heptopyranosylamino-9H-purine) Parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics 02/21/2014 Designated/Withdrawn
70 (6aR, 10aR)-3-(1’,1’-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid Treatment of cystic fibrosis. 10/13/2015 Designated
71 (6aR, 10aR)-3-(1⿿,1⿿-dimethylheptyl)-ο8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis 06/10/2015 Designated
72 (6R,S)5,10-methylene-tetrahydrofolic acid For use in combination with 5-fluorouracil for the treatment of patients with pancreatic cancer 08/13/2004 Designated
73 (7S)-(+)-8,8-Dimethyl-7-(3-phenyl-allyloxy)-7,8-dihydro-6H-pyrano3,2-gchromen-2-one Treatment of Werner syndrome 02/05/2020 Designated
74 (7S,13R)-11-fluoro-7,13-dimethyl-6,7,13,14-tetrahydro-1,15-ethenopyrazolo4,3-f1,4,8,10benzoxatriazacyclotridecin-4(5H)-one Treatment of non-small cell lung adenocarcinomas with adenocarcinoma histology 06/22/2017 Designated
75 (9-N-(3-morpholinopropyl)-sulfonyl-5,6-dihydro-5-oxo-11-H-indeno 1,2-c isoquinoline methanesulfonic acid Prevention of post-operative complications of aortic anuerysm surgical repair 12/08/2004 Designated
76 (E)-3-(6-Bromo-pyridin-2-yl)-2-cyano-N-((S)-1-phenyl-ethyl)-acryl amide Treatment of glioblastoma 02/01/2019 Designated
77 (E)-N1-(3-(dimethylamino)propyl)-N8-hydroxy-2-((naphthalen-1-yloxy)methyl)oct-2-enediamide phosphate Treatment of Pancreatic cancer 08/26/2019 Designated
78 (E)-N’-(1-(5-Chloro-2-hydroxy phenyl)Ethylidene)-3-((4-Methyl Piperazin-1-yl) Sulfonyl) Benzohydrazide Mesylate Treatment of Ewing's sarcoma. 01/12/2017 Designated
79 (E, Z)-4,5,9-trithiadodeca-1, 6, 11-triene 9-oxide (Ajoene) Treatment of Pseudomonas aeruginosa pulmonary infections in cystic fibrosis patients 04/21/2016 Designated/Withdrawn
80 [[(N-{2-(6-{(2,6-Dichloro-3,5-dimethoxyphenyl)carbamoyl(methyl)amino}pyrimidin-4- yl)amino-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide)]] Treatment of hepatocellular carcinoma (HCC) 09/07/2017 Designated
81 (R)-1-phenylethyl-5-(4-biphenyl-4-cyclopropanecarboxylic acid)-3-methylisoxazole-4-yl carbamate sodium salt Treatment of idiopathic pulmonary fibrosis 04/15/2011 Designated
82 (R)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-1,2,4triazolo4,3-apyrimidin-5-yl)phenyl)-N,N,N-trimethylethanaminium methanesulfonate dehydrate Treatment of cystic fibrosis 01/25/2017 Designated
83 (R)-2-hydroxy-2-methyl-4-(2,4,5-trimethyl-3,6-dioxocyclohexa-1,4-dien-1-yl) butanamide Treatment of amyotrophic lateral sclerosis 07/27/2017 Designated
84 [[(R)-2-methyl-6-nitro-2-{4-4-(4-trifluoromethoxyphenoxy)piperidin-1-ylphenoxymethyl}-2,3-dihydroimidazo2,1-boxazole]] Treatment of pulmonary tuberculosis. 07/12/2007 Designated
85 [[(R)-3-(4-{1-1-(3-Carboxy-1-cyclopropyl-7-fluoro-9-methyl-4-oxo-4H-quinolizine-8-yl)-pyrrolidin-3-yl-cyclopropyl-methylamino}-piperidin-1-ylimino)-methylenyl-rifamycin]] Treatment of prosthetic joint infection 01/14/2020 Designated
86 (R)-3-3-Fluoro-4-(1-methyl-1,4,5,6-tetrahydro-1,2,4-triazin-4-yl)phenyl-5(R)-(hydroxymethyl)oxazolidin-2-one Treatment of tuberculosis 07/19/2017 Designated
87 [[(R)-4-(3-morpholin-4-yl-1-phenylsulfanylmethyl-propylamino)-N-(4-{4-2-(4-chlorophenyl)-5,5-dimethylcyclohex-1-enylmethyl-piperazin-1-yl}-benzoyl)-3-trifluoromethanesulfonylbenzenesulfonamide bis-hydrochloride]] Treatment of multiple myeloma 05/05/2008 Designated/Withdrawn
88 [[(R)-4-(3-morpholin-4-yl-l-phenylsulfanylmenthyl-propylamino)-N-(4-{4-2-(4-chlorophenyl)-5,5-dimethylcyclohex-l-enylmethyl-piperazin-l-yl}-benzoyl)-3-trifluoromethanesulfonylbenzenesulfonamide bis-hydrochloride]] Treatment of chronic lymphocytic leukemia 12/19/2007 Designated/Withdrawn
89 (R)-6-((3,3-difluoro-1-methylpiperidine-4-yl)oxy-N-(3-ethynyl-2-fluorophenyl)-7-methoxyquinazolin-4-amine-,fumerate (2:1) (salt) Treatment of glioma (including glioblastoma and anaplastic astrocytoma) 07/24/2019 Designated
90 (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzohquinazolin-2-amine dihydrochloride Treatment of cholangiocarcinoma. 11/19/2015 Designated
91 (R)-Azasetron besylate Prevention of platinum-induced ototoxicity in pediatric patients 08/16/2017 Designated
92 (R)-N-(1-(1-(1H-indazol-5-yl)-3-methyl-2,4-dioxo-1,3,8-triazaspiro4,5decan-8-yl)-3-methyl-1-oxobutan-2-yl)-2-fluoro-5-(trifluoromethyl)benzamide Treatment of idiopathic pulmonary fibrosis 07/18/2019 Designated
93 (R)-N-2-(6-chloro-5-methoxy-1H-indol-3-yl)propylacetamide Treatment of circadian rhythm sleep disorders in blind people with no light perception 10/03/2001 Designated
94 (R)-N-2-(6-Chloro-methoxy-1H-indol-3yl)propylacetamide Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia patients 07/03/2003 Designated
95 (R)-praziquantel Treatment of schistosomiasis 06/27/2017 Designated
96 (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4-yl)pyridin-2-yl)pyrrolo1,2-bpyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate Treatment of fibrodysplasia ossificans progressiva 08/08/2019 Designated
97 (RS)-baclofen, naltrexone and D-sorbitol Treatment of Charcot-Marie-Tooth disease type 1A 03/17/2014 Designated
98 (S)-1-(6,7-Dihydro-5H-benzo6,7cyclohepta1,2-cpyridazin-3-yl)-N3-(7-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo7annulen-2-yl)-1H-1,2,4-triazole-3,5-diamine Treatment of acute myeloid leukemia 11/05/2014 Designated
99 (S)-10-(dimethylamino)methyl-4-ethyl-9hydroxy-4-O-a-(2",4",5",7"-tetranitro-9"-fluorenylideneaminooxy)propionyl- 1H-pyrano3',4',6',7', indolizino 1,2-B-quinoline-3, 14-(4H, 12H)-dione, hydrochloride Treatment of hepatocellular carcinoma 10/06/2010 Designated
100 (S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo2,1-f1,2,4triazine-5-carbonitrile Treatment of pemphigus vulgaris 01/26/2015 Designated/Withdrawn
101 (S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl3,4-dihydropyrrolo2,1-f1,2,4triazine-5-carbonitrile Treatment of epidermolysis bullosa acquisita 01/05/2017 Designated/Withdrawn
102 (S)-2-(1-(9H-purin-6-ylamino)propyl)-3-(3-fluorophenyl)-4H-chromen-4-one) Treatment of peripheral T-cell lymphoma 12/18/2017 Designated
103 (S)-3-((3-(1-((6-((3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium Treatment of pulmonary arterial hypertension 11/17/2014 Designated
104 (S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid Treatment of primary sclerosing cholangitis (PSC) 06/21/2017 Designated
105 (S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano3',4':6,7indolizino1,2-bquinolin-9-yl 4-(2-(5-(3-(2,4-dihydroxy-5-isopropylphenyl)-5-hydroxy-4H-1,2,4-triazol-4-yl)-1H-indol-1-yl)ethyl)piperidine-1-carboxylate Treatment of pancreatic cancer 07/24/2019 Designated
106 (S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano3',4':6,7indolizino1,2-bquinolin-9-yl 4-(2-(5-(3-(2,4-dihydroxy-5-isopropylphenyl)-5-hydroxy-4H-1,2,4-triazol-4-yl)-1H-indol-1-yl)ethyl)piperidine-1-carboxylate Treatment of Small Cell Lung Cancer 10/10/2019 Designated
107 (S)-4,5-dihydro-22-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl-4-methyl-4-thiaxolecarboxylic acid Treatment of chronic iron overload in patients with transfusion-dependent anemias 02/04/2009 Designated/Withdrawn
108 (S)-4-methyl-5-((4-((2-(methylamino)-6-(2,2,2-trifluoroethyl)thieno2,3-dpyrimidin-4-yl)amino)piperidin-1-yl)methyl)-1-(2-(4-(methylsulfonyl)piperazin-1-yl)propyl)-1H-indole-2-carbonitrile Treatment of acute myeloid leukemia 07/22/2019 Designated
109 (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride Treatment of inherited mitochondrial respiratory chain diseases 11/17/2014 Designated
110 (S)-7-(1-(9H-purin-6-ylamino)ethyl)-6-(3-fluorophenyl)-3-methyl-5H-thiazolo3,2-apyrimidin-5-one Treatment of Hodgkin lymphoma 04/29/2015 Designated
111 (S)-perillyl alcohol temozolomide Treatment of glioma 11/12/2014 Designated
112 (s)-perillyl alcohol temozolomide carbamate Treatment of nasopharyngeal carcinoma 07/27/2017 Designated
113 (s)-perillyl alcohol temozolomide carbamate Treatment of intracranially located metastases from breast cancer 02/28/2017 Designated
114 (tisagenlecleucel) Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 For the treatment of Acute Lymphoblastic Leukemia 01/31/2014 Designated/Approved
115 (UDU-stereoisomer of c-UJUun UNU-terminal UkUnhibitor) Treatment of acute sensorineural hearing loss 03/28/2006 Designated
116 1 8-(p131I-iodophenyl)octadecyl phosphocholine Treatment of multiple myeloma 12/03/2014 Designated
117 [[1'-{5-(trifluoromethyl)-2-furylmethyl}spirofuro2,3-f1,3benzodioxole-7,3'-indol-2'(1'H)-one]] Treatment of erythromelalgia 11/19/2012 Designated
118 1,2:5,6-Dianhdrogalactitol Treatment of malignant gliomas 01/31/2012 Designated
119 1,2:5,6-dianhydrogalactitol Treatment of ovarian cancer. 04/19/2016 Designated
120 1,2:5,6-dianhydrogalactitol Treatment of medulloblastoma. 03/10/2016 Designated
121 1,4-diamino-2,3-dicyano-1,4-bis2-aminophenylthio butadiene Treatment of subarachnoid hemorrhage (SAH) 08/03/2017 Designated
122 1,5-(Butylimino)-1,5 dideoxy,D-glucitol Treatment of Fabry's disease. 05/12/1998 Designated
123 1-(((Z)-hexadec-1-en-1-yl)oxy)-3-((2-oxido-1,3,2-oxazaphospholidin-2-yl)oxy)propan-2-yl (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoate Treatment of Rhizomelic Chondrodysplasia Punctata 08/08/2019 Designated
124 1-((2S,4S)-2-((((S) -(4-bromophenoxy)(((S)-1-oxo-1-(((S)- pentan-2-yl)oxy)propan-2-yl)amino)phosphoryl)oxy)methyl)-1,3-dioxolan-4-yl)-2-oxo-1,2-dihydropyrimidin-4- aminium chloride Treatment of Hepatocellular Carcinoma 05/04/2020 Designated
125 1-(11-dodecylamino-10-hydroxyundecyl)-3,7-dimethylxanthine hydrogen methanesulfonate Treatment of hormone refractory prostate carcinoma. 01/18/2000 Designated/Withdrawn
126 1-(2,8-Dimethyl-1-thia-3,8-diazaspiro4.5dec-3-yl)-3-(1H-indol-3-yl)propan-1-one Treatment of frontotemporal dementia. 04/06/2016 Designated
127 1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine Treatment of acute myelogenous leukemia 06/24/2010 Designated
128 1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine Treatment of myelodysplastic syndrome 06/24/2010 Designated
129 1-(2-chlorophenyl)-1-(S)-hydroxy-2-(S)-carbamoyloxy-propane Treatment of status epilepticus 07/07/2016 Designated
130 1-(2-chlorophenyl)-1-(S)-hydroxy-2-(S)-carbamoyloxy-propane Treatment of infantile spasms 03/20/2017 Designated
131 [[1-(2-hydroxyethyl)-8-{5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenylamino}-4,5-dihydro-1H-pyrazolo4,3-hquinazoline-3-carboxamide fumarate salt]] Treatment of Acute Myeloid Leukemia 09/28/2017 Designated
132 1-(2-Nitro-imidazolyl)-3-18Ffluoro-2-propanol; 1H-1-(3-18Ffluoro-2-hydroxypropyl0-2-nitroimidazole (18F-Misonidazole) Diagnostic for management of glioma. 04/06/2016 Designated
133 1-(2-Nitro-imidazolyl)-3-18Ffluoro-2-propanol;1H-1-(3-18Ffluoro-2-hydroxypropyl)-2-nitroimidazole As a diagnostic for clinical management of soft tissue sarcoma, including rhabdomyosarcoma. 01/06/2016 Designated
134 [[1-(3-{4-3,4-difluoro-2-(trifluoromethyl)phenylpiperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo3,4-cpyridin-6-yl)ethan-1-one]] Treatment of Stargardt disease 09/19/2017 Designated
135 1-(4-(benzylamino)-7,8-dihydro-5H-pyrano4,3-dpyrimidin-2-yl)-2-methyl-1H-indole-4-carboxamide Treatment of multiple myeloma 07/08/2015 Designated/Withdrawn
136 1-(4-benzhydrylpiperazin-1-yl)-3,3-diphenylpropan-1-one Management of postherpetic neuralgia 09/26/2013 Designated/Withdrawn
137 1-(4-Chloro-3,5-diphenyl-pyrazolo3,4-cpyridazin-1-yl)-2-methyl-propan-2-ol Treatment of Usher syndrome 11/26/2019 Designated
138 [[1-(4-{4-amino-7-1-(2-hydroxyethyl)-1H-pyrazol-4-ylthieno3,2-cpyridine-3-yl}phenyl)-3-(3-fluorophenyl)urea)]] Treatment of acute myelogenous leukemia 07/28/2011 Designated/Withdrawn
139 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid Treatment of systemic sclerosis 03/31/2015 Designated
140 1-(fluoro-18F)-3-((2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dien-1-yl)benzodthiazol-6-yl)oxy)propan-2-ol A diagnostic for the management of progressive supranuclear palsy 11/01/2017 Designated
141 1-118-signal regulatory protein alpha (human) fusion protein with immunoglobulin G1 (human Fc fragment), dimer Treatment of Cutaneous T-Cell Lymphoma 03/08/2018 Designated
142 1-Cyclopropyl-3-3-(5-morpholin-4-ylmethyl-1H-benzoimidazol-2-yl)-1H-pyrazol-4-yl-urea Treatment of acute myeloid leukemia 11/12/2009 Designated
143 1-(2-Chloro-4-methoxyphenoxy)methyl-4-(2,6-dichlorophenoxy) methylbenzene Treatment of poliovirus infection. 01/09/2012 Designated
144 1-(3S)-4-amino-3-(3,5-dimethoxyphenyl)ethynyl-1H-pyrazolo3,4-dpyrimidin-1-yl-1-pyrrolidinyl-2-propen-1-one Treatment of cholangiocarcinoma (CCA) 05/23/2018 Designated
145 [[1-{2-3-(3,4-Dichlorophenyl)ureido-6-methyl-pyrimidin-4-yl}-amino-3(dimethylamino)propane Di methansulfonate]] Treatment of glioma 08/02/2017 Designated
146 [[1-{4-2-(5-ethoxymethyl-2-methyl-phenylamino)-oxazol-5-yl-phenyl}-imidazolidin-2-one]] Treatment of acute myeloid leukemia 08/01/2019 Designated
147 10 synthetic peptides targeting 5 tumor asociated antigens Treatment of non-small cell lung cancer in patients expressing HLA-A2 01/23/2013 Designated
148 10-nitro-9(E)-octadec-9-enoic acid Treatment of pulmonary arterial hypertension 09/12/2019 Designated
149 111Indium pentetreotide Treatment of somatostatin receptor positive neuroendocrine tumors. 06/10/1999 Designated
150 12-A-p21 RAS(5-21). 12-C-p21 RAS(5-21). 12-D-p21 RAS(5-21). 12-Rp21 RAS(5-21). 12-S-p21 RAS(5-21). 12-V-p21 RAS(5-21). 13-D-p21 RAS(5-21) Treatment of pancreatic cancer 06/07/2011 Designated
151 131-I-8H9 monoclonal antibody Treatment of neuroblastoma 08/29/2016 Designated
152 131I-BC8 monoclonal antibody (Anti-CD45 murine monoclonal antibody radiolabeled with 131I Treatment of Acute Myeloid Leukemia (AML) 03/28/2016 Designated
153 14-amino acid peptide derived from wound growth factor Prevention of delayed graft function in renal transplant recipients 08/05/2010 Designated/Withdrawn
154 14-amino acid peptide derived from wound growth factor Treatment of delayed graft function in renal transplant recipients 08/16/2010 Designated/Withdrawn
155 15(S)-hydroxy-(5Z,8Z,11Z,13E,17Z)-eicosapentaenoic acid ethyl ester Treatment of idiopathic pulmonary fibrosis 12/17/2018 Designated
156 16 base single stranded peptide nucleic acid oligonucleotide – 7 aminoacids peptide Treatment of Small Cell Lung Cancer 02/22/2018 Designated
157 16 base single stranded PNA oligonucleotide–7 aminoacids peptide Treatment of neuroblastoma 10/25/2017 Designated
158 17 amino acid peptide Prevention of ischemia reperfusion injury in the lung during lung tranplantation 01/29/2010 Designated
159 17-a-hydroxyprogesterone caporate (oral formulation) Prevention of preterm birth in women with a singleton pregnancy 06/01/2015 Designated
160 17-allylamino-17-demethoxygeldanamycin (17-AGG) Treatment of chronic myelogenous leukemia 09/03/2004 Designated
161 177-LU-DOTA-GlyGlyNle-CycMSHhex Treatment of Stage IIB through IV malignant melanoma 04/16/2015 Designated
162 177Lu-tetraxetan-tetulomab Treatment of Follicular Lymphoma 05/14/2014 Designated
163 18-(p-124I-iodophenyl)octadecyl phosphocholine Diagnostic for the management of glioma 04/30/2014 Designated/Withdrawn
164 18-(p-131-iodophenyl)octadecyl phosphocholine Treatment of neuroblastoma 03/15/2018 Designated
165 18-(p-131I-iodophenyl)octadecyl phosphocholine Treatment of osteosarcoma 09/24/2018 Designated
166 18-(p-131I-iodophenyl)octadecyl phosphocholine Treatment of Lymphoplasmacytic Lymphoma/Waldenstrom macroglobulinemia 12/23/2019 Designated
167 18-(p-131I-iodophenyl)octadecyl phosphocholine Treatment of Ewing’s Sarcoma 07/03/2018 Designated
168 18-(p-131I-iodophenyl)octadecyl phosphocholine Treatment of soft tissue sarcomas including rhabdomyosarcoma 05/08/2018 Designated
169 18-mer antisense oligonucleotide complementary to SCN1A mRNA Treatment of Dravet syndrome 08/05/2019 Designated
170 18F-meta-fluorobenzylguanidine Diagnostic for the management of neuroblastoma 08/21/2019 Designated
171 18Fluorine-N-3-Fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl) Nortropane Diagnostic to be used in the management of multiple system atrophy (MSA) 01/26/2015 Designated
172 1E,6E)-1,7-Bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione or (1E, 4Z,6E)-4-(cyclobutylmethyl)-1,7-bis(3,4-dimethoxyphenyl)-5-hydroxyhepta-1,4,6-trien-3-one Treatment of spinal and bulbar muscular atrophy 02/17/2016 Designated
173 2 dimethylbutyrate Treatment of beta thalassemia 06/18/2008 Designated
174 2',3',5'-tri-o-acetyluridine Treatment of mitochondrial disease 01/13/2003 Designated/Withdrawn
175 2'-3'-dideoxyadenosine Treatment of aquired immunodeficiency syndrome. 07/21/1987 Designated/Withdrawn
176 2'-deoxycytidine As a host-protective agent in the treatment of acute myelogenous leukemia. 09/09/1996 Designated
177 2'-O-(2-methoxyethyl)phosphorothioate antisense oligonucleotide Treatment of acromegaly 05/10/2016 Designated
178 2'-O-methyl phosphorothioate 5'-GCUAGGUUUACGGGACCUCU-3' Treatment of amyotrophic lateral sclerosis 10/31/2012 Designated
179 [[2,2'-{2-1R)-1-({(2,5-dichlorobenzoyl)aminoacetyl}amino)-3-methylbutyl-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid (ixazomib citrate)]] Treatment of systemic light chain (AL) amyloidosis. 03/09/2012 Designated
180 2,4-dinitrophenol Treatment of Huntington disease 02/11/2019 Designated
181 2,5-dimethyl-3-2-methyl-4-(methyloxy)phenyl-N-(1S)-1-(3-methyl-1,2,4-oxadiazol-5- Treatment of congenital adrenal hyperplasia (CAH) 01/15/2015 Designated/Withdrawn
182 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo1,2-apyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile Treatment of idiopathic pulmonary fibrosis. 06/08/2017 Designated
183 2-((4S)-6-(4-chlorophenyl)-1-methyl-4H-benzocisoxazolo4,5-eazepin-4-yl) acetamide monohydrate Treatment of myelofibrosis 11/20/2019 Designated
184 [[2-(1,1-difluoroethyl)-5-methyl-N-4-(pentafluoro-¿{6}-sulfanyl)phenyl-1,2,4triazolo1,5-apyrimidin-7-amine]] Treatment of malaria 08/18/2017 Designated
185 2-(2-chlorobenzylidene)hydrazinecarboximidamide acetate Treatment of Charcot-Marie Tooth disease. 09/10/2015 Designated
186 2-(2-chlorophenyl)-4-3-(dimethylamino)phenyl-5-methyl-1H-pyrazolo4,3-Cpyridine-3,6(2H,5H)-dione Treatment of idiopathic pulmonary fibrosis. 09/21/2010 Designated
187 2-(2-phenylvinyl)-4--methylpiperazin-l-yl)-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt Treatment of acute myeloid leukemia. 01/29/2010 Designated
188 2-(2-phenylvinyl)-4-4-methylpiperazin-1-yl)-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt Treatment of hepatocellular carcinoma 07/01/2014 Designated
189 2-(2-phenylvinyl)-4-4-methylpiperazin-l-yl)-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt Treatment of multiple myeloma. 12/22/2008 Designated
190 2-(2-phenylvinyl)-4-4-methylpiperazin-l-yl)-6-(5-methyl-2H-pyrazol-3-ylamino)-pyrimidine L(+) tartrate salt Treatment of ovarian carcinoma 03/18/2009 Designated
191 [[2-(2-{2-(1H-benzimidazol-2-yl)ethylamino}ethyl)-N-(3-fluoropyridin-2-yl)methyl-1,3-oxazole-4-carboxamide trihydrochloride]] Treatment of beta-thalassemia 06/17/2019 Designated
192 2-(3,5-difluoro-3'-methoxybiphenyl-4-ylamino)nicotinic acid Treatment of acute myeloid leukemia 08/16/2018 Designated
193 2-(3,7-Dimethyl-octa-2, 6-dienyl)—6-ethylamino-3-hydroxy-5-pentyl-1,4benzoquinone Treatment of Huntington’s Disease (HD) 02/01/2018 Designated
194 2-(3-(4-(7H-pyrrolo2,3-dpyrimidin-4-yl)-1H-pyrazol-l-yl)-1-(1-(3-fluoro-2-(trifluoromethyl)isonicotinoyl)piperidin-4-yl)azetidin-3-yl)acetonitrile adipate Treatment of pancreatic cancer 01/26/2015 Designated
195 2-(3-amino-6-chloroquinolin-2-yl)-propan-2-ol Treatment of congenital ichthyosis 04/17/2017 Designated
196 2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro 4,5 decan dimaleate Treatment of mulitple myeloma and associated bone resorption 12/02/2003 Designated
197 2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro4,5 decane dimaleate Treatment of carcinoid tumors 09/18/2006 Designated
198 2-(4-(2,4-dichlorophenethyl)-3,6-dioxo-1-(2-(thiophen-2-yl)ethyl)piperazin-2-yl)-N-(2-(5-methoxy-1H-indol-3-yl)ethyl) acetamide Prevention of platinum-induced ototoxicity in pediatric patients 12/14/2017 Designated/Withdrawn
199 2-(4-oxo-3-((5-(trifluoromethyl)benzodthiazol-2-yl)methyl)-3,4-dihydrothieno3,4-dpyridazin-1-yl)acetic acid Treatment of Galactosemia 05/23/2019 Designated
200 2-(5-fluoro-2-methyl-1H-indol-3-yl)-1H-imidazo4,5-f1,10 phenanthroline Treatment of acute myeloid leukemia 06/01/2015 Designated
201 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzodoxazol-6-yl)acetamide Treatment of cystic fibrosis 05/13/2015 Designated
202 2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-tetrakisphosphate Treatment of cystic fibrosis 08/15/2003 Designated
203 2-0-desulfated heparin Treatment of cystic fibrosis. 09/17/1993 Designated
204 2-amino-1-2-(4-fluoro-phenyl)-3-(4-fluoro-phenyl)amino)-8,8-dimethyl-5,6-dihydro-imidazo1,2-apyrazin-7(8H)-yl)-ethanone diphosphate Treatment of malaria. 05/11/2017 Designated
205 2-amino-2-2-2-chloro-4-3-(phenylmethoxy) phenyl thiophenylethyl1,3-propanediol hydrochloride Prevention of graft versus host disease. 10/06/2015 Designated/Withdrawn
206 2-amino-3-3-4-(2-pyridyloxymethyl)phenylmethylisoxazol-5-ylpyridin-1-ium-1-ylmethyl hydrogen phosphate Treatment of invasive candidiasis 10/19/2016 Designated
207 2-amino-3-3-4-(2-pyridyloxymethyl)phenylmethylisoxazol-5-ylpyridin-1-ium-1-ylmethyl hydrogen phosphate Treatment of invasive aspergillosis 10/26/2016 Designated
208 2-amino-3-3-4-(2-pyridyloxymethyl)phenylmethylisoxazol-5-ylpyridin-1-ium-1-ylmethyl hydrogen phosphate Treatment of coccidioidomycosis 11/03/2016 Designated
209 2-amino-3-3-4-(2-pyridyloxymethyl)phenylmethylisoxazol-5-ylpyridin-1-ium-1-ylmethyl hydrogen phosphate Treatment of invasive rare mold infections caused by scedosporium spp., fusarium spp., and mucorales fungi (including mucor spp., and rhizopus spp.) 11/02/2016 Designated
210 2-Amino-4-11Cmethylsulfanyl-butanoic acid, l-S methyl11Cmethionine Diagnostic agent for the Clinical Management of Medulloblastoma 01/17/2017 Designated
211 [[2-amino-N-({methyl-(6-trifluoromethoxy-benzothiazol-2-ylcarbamoyl)-methyl-carbamoyl}-methyl)-acetamide monohydrochloride]] Treatment of spinocerebellar ataxia. 05/18/2016 Designated
212 2-Chloro-N6--(3-iodobenzyl)adenosine-5'-N-methyluronamide Treatment of hepatocellular carcinoma 02/17/2012 Designated
213 2-chloroethyl-3-sarcosinamide-1-nitrosourea Treatment for malignant glioma 11/15/2001 Designated
214 2-chloroethyl-3-sarcosinamide-1-nitrosourea Treatment for malignant gliomas 08/03/2001 Designated
215 2-hydroxy-N,N,N-trimethylethan-1-aminium (Z)-4-(5-((3-benzyl-4-oxo-2-thioxothiazolidin-5-ylidene)methyl)furan-2-yl)benzoate Treatment of Pancreatic Cancer 09/11/2019 Designated
216 2-hydroxymethyl-2-methoxymethyl-1-azabicyclo2,2,2octan-3-one Treatment of Myelodysplastic Syndrome 04/11/2019 Designated
217 2-hydroxypropyl-B-cyclodextrin Treatment of Niemann Pick disease, type C. 02/18/2013 Designated
218 2-iminobiotin Treatment of perinatal asphyxia. 02/24/2009 Designated
219 2-isopropyl-3H-naphtho1,2-dimidazole-4,5-dione Treatment of inherited mitochondrial respiratory chain disease 04/16/2018 Designated
220 2-methoxyestradiol Treatment of multiple myeloma 07/10/2001 Designated/Withdrawn
221 2-methoxyestradiol Treatment of ovarian cancer 04/04/2005 Designated/Withdrawn
222 2-methoxyestradiol Treatment of multiforme glioblastoma 06/16/2006 Designated/Withdrawn
223 2-methoxyestradiol Treatment of pulmonary arterial hypertension 04/11/2005 Designated
224 2-O, 3-O, desulfated heparin Treatment of acute myeloid leukemia 12/21/2017 Designated
225 2-Pyrazinecarbonitrile, 5-5-2-(3-aminopropoxy)-6-methoxyphenyl-1H-pyrazol-3-ylamino monomesylate monohydrate Treatment of anal cancer 04/09/2015 Designated
226 2-(2S)-1-azabicyclo2.2.2oct-2-yl-6-(3-methyl-1H-pyrazol-4-yl)thieno3,2-dpyrimidin-4(3H)-one hemihydrate Treatment of esophageal cancer 02/11/2019 Designated
227 2-(2S)-2-methyl-1,4-dioxa-8-azaspiro4.5dec-8-yl-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one Treatment of Tuberculosis (TB) 03/15/2018 Designated
228 2-(3-methyl-4-(2,2,2-trifluoroethoxy) pyridin-2-yl)methylsulfinyl -1H-benzoimidazole Treatment of hepatocellular carcinoma. 08/27/2008 Designated
229 2-(4S)-6-(4-chlorophenyl)-1,7,8-trimethylthiophenol3,2-f1,2,4-triazolo4,3-a1,4-diazepin-4-yl-N-3-(4-methylpiperazinyl)propylacetamide Treatment of nuclear protein in testis (NUT) midline carcinoma. 09/29/2015 Designated/Withdrawn
230 2-(6S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thienol3,2,-f-1,2,4triazolo4,3-a1,4diazepin-6-yl-N-(4-hydroxyphenyl)-acetamide dihydrate Treatment of acute myeloid leukemia 07/16/2014 Designated
231 2-(R)-2-methylpyrrolidin-2-yl-1H-benzimadazole-4-carboxamide Treatment of malignant melanoma stages IIb through IV. 12/18/2007 Designated
232 [[2-3-(2-chloro-4-{5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-ylmethoxy}phenyl)-3-hydroxyazetidin-1-ylpyridine-4-carboxylic acid—2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1)]] Treatment of Primary Sclerosing Cholangitis (PSC) 10/25/2018 Designated
233 2-4-(1-Methyl-4-pyridin-4-yl-lH-pyrazol-3-yl)-phenoxymethyl-quinoline succinic acid Treatment of Huntington's disease. 06/02/2014 Designated/Withdrawn
234 2-4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino-indian-2-carboxylic acid Treatment of patients with systemic sclerosis 05/14/2013 Designated
235 2-4-(2-R)-2-ethoxy-3-4-(trifluoromethyl)phenoxypropylthio-2-methylphenoxyacetic acid (1:1) lysine dihydrate Treatment of patients with Frederickson Type I or V hyperlipoproteinemia 04/15/2015 Designated
236 2-4-(2R)-2-ethoxy-3-4-(trifluoromethyl)phenoxypropylthio-2-methylphenoxyacetic acid (1:1) lysine dihydrate Treatment of primary biliary cholangitis 11/07/2016 Designated
237 2-4-(2R)-2-ethoxy-3-4-(trifluoromethyl)phenoxypropylthio-2-methylphenoxyacetic acid (1:1) lysine dihydrate Treatment of homozygous familial hypercholesterolemia (HoFH) 03/18/2015 Designated
238 [[2-3-({4-(5-{2-(3-Fluorophenyl)amino-2-oxoethyl}-1H-pyrazol-3-yl)amino-quinazolin-7-yl}propyl(ethyl)aminoethyl dihydrogen phosphate trihydrate]] Treatment of acute myeloid leukemia 01/19/2010 Designated
239 [[2-{3-(3R)-3-({2-chloro-3-(trifluoromethyl)phenylmethyl}(2,2-diphenylethyl)amino)butoxyphenyl}acetic acid]] Treatment of ovarian cancer. 06/16/2015 Designated
240 [[2-{3-(3R)-3-({2-chloro-3-(trifluoromethyl)phenylmethyl}(2,2-diphenylethyl)amino)butoxyphenyl}acetic acid]] Treatment of malignant melanoma stages IIB to IV. 06/23/2015 Designated
241 [[2-{3-(3R)-3-({2-chloro-3-(trifluoromethyl)phenylmethyl}(2,2-diphenylethyl)amino)butoxyphenyl}acetic acid]] Treatment of glioblastoma multiforme. 06/16/2015 Designated
242 [[2-{4-(9R)-9-Hydroxy-2-(3-hydroxy-3-methylbutyloxy)-9-(trifluoromethyl)-9H-fluoren-4-yl-1H-pyrazol-1-yl}-2-methylpropanamide monohydrate]] Treatment of pulmonary arterial hypertension 01/23/2018 Designated
243 [[2-{(1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexymethoxy} acetic acid]] Treatment of pulmonary arterial hypertension 08/28/2014 Designated
244 20% Lipid emulsion solution Treatment of local anesthetic systemic toxicity 06/08/2017 Designated
245 20-hydroxyecdysone Treatment of Duchenne Muscular Dystrophy 05/10/2018 Designated
246 20-mer complementary to Akt mRNA Treatment of stomach cancer 12/10/2004 Designated
247 20-mer oligonucleotide complementary to Akt mRNA Treatment of pancreatic cancer 12/08/2004 Designated
248 20-mer oligonucleotide complementary to Akt mRNA Treatment of glioblastoma 12/08/2004 Designated
249 20-mer oligonucleotide complementary to Akt mRNA Treatment of renal cell carcinoma 12/01/2004 Designated
250 20-mer oligonucleotide complementary to Akt mRNA Treatment of ovarian cancer 12/01/2004 Designated
251 225Ac-lintuzumab Treatment of acute myelogenous leukemia 11/25/2014 Designated
252 24,25 dihydroxycholecalciferol Treatment of uremic osteodystrophy. 02/27/1987 Designated
253 2S,4R ketoconazole Treatment of endogenous Cushing's syndrome 03/09/2012 Designated
254 2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting exon 13 in the USH2A gene Treatment of retinitis pigmentosa 11/20/2017 Designated
255 3'-azido-2',3'dideoxyuridine Treatment of acquired immunodeficiency syndrome. 11/20/1989 Designated/Withdrawn
256 3,4 diaminopyridine and choline bitartrate Treatment of Lambert-Eaton myasthenic syndrome 04/30/2010 Designated
257 3,4-diaminopyridine Treatment of congenital myasthenic syndrome (CMS) 03/30/2017 Designated
258 3,5,3'-triiodothyroacetate Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid gland. 09/20/2000 Designated
259 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R, 5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide Treatment of Primary Ciliary Dyskinesia 05/05/2020 Designated
260 3,5-diiodothyropropionic acid Treatment of Allan-Herndon-Dudley syndrome 05/14/2013 Designated
261 3-(1’-butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-N-butylimide methyl ester Treatment of glioma 12/06/2017 Designated
262 3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one Treatment of von Hippel-Lindau disease. 03/23/2000 Designated
263 3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one Treatment of Kaposi's sarcoma. 09/11/1998 Designated
264 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-pyrazol-1-yl) propanoic acid Treatment of Stargardt’s disease. 04/22/2019 Designated
265 3-(3-(3,5-Dimethyl-1H-pyrazol-4- yl)propoxy)-4-fluorobenzoic acid Treatment of transthyretin amyloidosis 10/02/2018 Designated
266 3-(4-(1,5-Napthrydine)-Imidazole1,2-apyridine-7-(1-phenyl-4-(1-(4-methyl piperazine) Treatment of fibrodysplasia ossificans progressiva. 07/14/2015 Designated/Withdrawn
267 3-(4-(8-fluoroquinoline)-Imidazole1,2-apyridine-7-(1-phenyl-4-(1-(4-methyl piperazine) Treatment of fibrodysplasia ossificans progressiva. 07/14/2015 Designated/Withdrawn
268 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl) piperidine-2,6-dione hydrochloride Treatment of follicular lymphoma 03/12/2018 Designated
269 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride Treatment of diffuse large B-cell lymphoma 09/19/2016 Designated
270 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride Treatment of hepatocellular carcinoma (HCC) 07/03/2017 Designated
271 3-(5-Fluoro-benzofuran-3-yl)-4-(5-methyl-5H-1,3dioxolo4,5 findol-7-yl)-pyrrole-2,5-dione Treatment of Neuroblastoma 08/18/2017 Designated
272 3-(5-Fluoro-benzofuran-3-yl)-4-(5-methyl-5H-1,3dioxolo4,5-findol-7-yl)-pyrrole-2,5-dione Treatment of glioblastoma 03/29/2016 Designated
273 3-(6-(1-(2,2-difluorobenzod 1,3dioxyl-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Treatment of cystic fibrosis 03/02/2010 Designated/Withdrawn
274 3-aminopropyl-butyl phosphinic acid Treatment of succinic semialdehyde dehydrogenase deficiency. 12/13/2016 Designated
275 3-aminopyridine-2-carboxaldehyde thiosemicarbazone Treatment of stage 1B to IV cervical cancer 11/08/2017 Designated
276 3-bromo-2-oxopropanoic acid Treatment of stage IIb-IV melanoma 05/01/2020 Designated
277 3-bromopyruvate Treatment of liver and intrahepatic bile duct cancer 03/05/2013 Designated
278 3-bromopyruvate Treatment of pancreatic cancer 04/29/2014 Designated
279 3-chloro-4-fluorophenyl-4-fluoro-4-(5-methylpyrimidin-2-ylmethyl)aminomethylpiperidin-1ylmethanone Treatment of Rett syndrome 10/25/2013 Designated
280 3-fluoro-5-5-(2-menthyl-thiazol-4-ylethylnyl)-pyridin-2-yl-benzonitrile dihydrochloride Treatment of behavioral abnormalities associated with fragile X syndrome. 07/28/2008 Designated
281 3-pentylbenzenacetic acid sodium salt Treatment of idiopathic pulmonary fibrosis. 02/11/2015 Designated
282 3-pentylbenzeneacetic acid sodium salt Treatment of Alström syndrome 02/28/2017 Designated
283 3-2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid Prevention of acute attacks of angioedema in individuals with hereditary angioedema 12/23/2014 Designated/Withdrawn
284 3-3-(6-guanidino-1-oxoisoindolin-2yl) propanamido-3-(pyridine-3yl) propanoic acid dihydrochloride Treatment of retinopathy of prematurity 01/17/2017 Designated
285 3-4-(lH-imidazol-l-ylmethyl)phenyl-5-(2-methylpropyl) thiophene-2-(N-butyloxylcarbamate)-sulphonamide sodium salt Treatment of idiopathic pulmonary fibrosis 01/25/2017 Designated
286 3-5-(1R)-1-bis(aziridin-1-yl(phosphoryloxyethyl-2-nitrophenoxy-N,N-dimethylbenzamide Treatment of Acute Lymphoblastic Leukemia 09/17/2018 Designated
287 3-5-(1R)-1-bis(aziridin-1-yl(phosphoryloxyethyl-2-nitrophenoxy-N,N-dimethylbenzamide Treatment of hepatocellular carcinoma 07/03/2018 Designated
288 [[3-{3-4-(1-aminocyclobutyl)phenyl-5-phenyl-3H-imidazo4,5-bpyridin-2-yl}cpyridin-2-amine bis-mesylate]] Treatment of Proteus Syndrome. 11/09/2015 Designated
289 4, 5 dibromorhodamine methyl ester Treatment of follicular lymphoma 10/30/2008 Designated
290 4, 5 dibromorhodamine methyl ester Treatment of diffuse large B-cell lymphoma 10/30/2008 Designated
291 4,5 dibromorhodamine methyl ester For immune reconstitution and prevention of graft versus host disease following allogeneic hematopoietic stem cell transplantation. 10/23/2007 Designated
292 4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol Treatment of Angelman syndrome. 09/06/2016 Designated
293 4,5-dibromorhodamine 123 Treatment of chronic myelogenous leukemia 04/10/2003 Designated/Withdrawn
294 4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo b,e1,4diazepin-11-one Treatment of malignant glioma. 04/27/2009 Designated/Withdrawn
295 4-(((3-chloro-1,4-dioxo-1,4 dihydronaphthalen-2-yl)amino)methyl)-N-(pyridine-3-yl)benzamide Treatment of Multiple Myeloma 02/28/2019 Designated
296 4-((2S,4S)-4-ethoxy-1-((5-methoxy-7-methyl-1H-indol-4-yl)methyl)piperidin-2-yl) benzoic acid Treatment of C3 glomerulopathy 05/18/2020 Designated
297 4-((7H-pyrrolo2,3-dpyrimidin-4-yl)amino)-N-(4-((4- methylpiperazin-1-yl)methyl)phenyl)-1H-pyrazole-3-carboxamide, (2Z)-2-butenedioate (1:2), Sesquihydrate Treatment of acute myeloid leukemia 11/26/2019 Designated
298 4-((L-valyl)oxy)butanoic acid Treatment of Narcolepsy 06/12/2019 Designated
299 4-(2-fluorophenyl)-6-methyl-2-(1-piperzinyl) Treatment of Chronic Functional Vomiting to include functional vomiting and cyclic vomiting syndrome. 10/11/2006 Designated
300 4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl Treatment of Huntington's disease. 12/12/2005 Designated
301 4-(4-((4-chloro-3-(trifluoromethyl)phenyl)sulfonyl)phenyl)-2,4-dihydro-3H-1,2,4-triazole-3-thione Treatment of amyotrophic lateral sclerosis 08/08/2019 Designated
302 4-(4-Methoxy-phenylamino)-6-methylcarbamyl-quinoline-3-carboxylic acid Prevention of scarring post ab externo glaucoma surgery 03/24/2015 Designated
303 [[4-(4-{2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-ylmethyl}piperazin-1-yl)-N-({3-nitro-4-(tetrahydro-2H-pyran-4-ylmethyl)aminophenyl}sulfonyl)-2-(1H-pyrrolo2,3-bpyridin-5-yloxy)benzamide]] Treatment of diffuse large B-cell lymphoma. 03/27/2014 Designated
304 4-(5-(2-chlorophenyl)-3-methyl-2,10-dihydropyrazolo4,3-b pyrido4,3-e1,4diazepin-8-yl) morpholine treatment of cholangiocarcinoma 11/06/2019 Designated
305 4-(6-(4-(piperazin-1-yl)phenyl_pyrazolo1,5-apyrimidin-3-yl)quinoline hydrochloride Treatment of fibrodysplasia ossificans progressiva 04/15/2013 Designated/Withdrawn
306 4-(pyrimidin-2-ylmethyl)-7-4-(trifluoromethoxy)phenyl-3,4-dihydro-1,4-benzoxazepin-5(2H)-one Treatment of congenital long QT syndrome 05/04/2015 Designated/Withdrawn
307 4-amino-1-(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl) cyclopent-2-en-1-yl pyrimidin-2-one Treatment of pancreatic cancer. 09/23/2014 Designated
308 4-amino-1-(2R,3S,4S,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrothiophen-2-yl pyrimidin-2(1H)-one Treatment of cholangiocarcinoma 08/01/2018 Designated
309 4-Amino-1-5-O-(2R, 4S)-2-oxido-4-(4-pyridinyl)-1, 3, 2-dioxaphosphorinan-2-yl-b-D-arabinofuranosyl-2(1H)-pyrimidinone Treatment of hepatocellular carcinoma. 08/22/2007 Designated
310 4-Aminopyridine Treatment chronic functional motor and sensory deficits from Guillain-Barre syndrome 12/14/2005 Designated
311 4-aminosalicylic acid Treatment of mild to moderate ulcerative colitis in patients intolerant to sulfasalazine. 12/13/1989 Designated
312 4-aminosalicylic acid Treatment of acute flares in pediatric patients with ileo-cecal Crohn's disease 04/26/2006 Designated
313 4-benzyl-2-(a-naphtyl)-1,2,4-thiadiazolidine-3,5-dione Treatment of progressive supranuclear palsy 10/13/2009 Designated/Withdrawn
314 4-Chloro-N-5-methyl-2-(7H-pyrrolo2,3-dpyrimidin-4-ylcarbonyl)-3-pyridinyl-3-(trifluoromethyl)benzenesulfonamide, sodium salt Treatment of focal segmental glomerulosclerosis 09/12/2018 Designated
315 4-cholest-en-3-one, oxime Treatment of amyotrophic lateral sclerosis 12/01/2005 Designated/Withdrawn
316 4-cyano-N-2-(1-cyclohexen-1-yl)-4-1-dimethylamino)acetyl-4-piperidinylphenyl-1H-imidazole-2-carboxamide monohydrochloride Treatment of acute myeloid leukemia 07/20/2006 Designated
317 4-demethyl-4-cholesteryloxycarbonylpenclomedine Treatment of non-small cell lung cancer with CNS metastases 09/19/2017 Designated
318 4-fluoro-5-((6-methylhexahydropyrrolo3,4-b pyrrol-5(1H)-yl) sulfonyl) isoquinoline Treatment of idiopathic pulmonary fibrosis 02/05/2020 Designated
319 4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl Treatment of cerebral cavernous malformation. 09/29/2015 Designated
320 4-Methyl-3-quinolin-3-ylethynylbenzoic acid N'-(2-chloro-6- methylbenzoyl) hydrazide Treatment of chronic myeloid leukemia 06/03/2019 Designated
321 4-methylpiperazine-1-carboxylic acid 1-(3-benzenesufonyl-1-phenethylallyl-carbamoyl)-2-phenylethyl amide Treatment of Chagas disease. 01/11/2017 Designated
322 4-Methylumbelliferone Treatment of Pancreatic Cancer 03/13/2020 Designated
323 4-Methylumbelliferone Treatment of Esophageal Carcinoma 04/20/2020 Designated
324 4-Methylumbelliferone Treatment of hepatocellular carcinoma 03/30/2020 Designated
325 4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide Treatment of pancreatic cancer. 11/02/2010 Designated
326 4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide Treatment of cholangiocarcinoma 03/30/2017 Designated
327 4-(2E)-1-Oxo-3-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-propen-1-yl-1-piperazinecarboxamide Treatment of retinitis pigmentosa 02/08/2016 Designated/Withdrawn
328 4-(7-Methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)-yl)methylbenzoic acid, hemifumarate Treatment of Ryanodine receptor type 1-related myopathies 08/17/2018 Designated
329 4-(7-Methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)-yl)methylbenzoic acid, hemifumarate Treatment of Catecholaminergic Polymorphic Ventricular Tachycardia 05/05/2020 Designated
330 4-(7-Methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)-yl)methylbenzoic acid, hemifumarate Treatment of patients with Duchenne Muscular Dystrophy. 11/18/2015 Designated
331 4-131Iiodo-L-phenylalanine Treatment of glioma. 01/04/2011 Designated
332 4-1benzofuro3,2-dpyrimidin-4-yl-N-(1,3-benzodioxol-5-ylmethyl)piperazine-1-carbothioamide Treatment, in combination with radiotherapy and temozolomide chemotherapy, of patients with glioblastoma multiforme. 07/30/2008 Designated
333 4-2-(3-Propyl-1,2,40xadiazol-5-yl)-vinyl-benzene-1,2-diol Treatment of chronic myeloid leukemia 10/04/2011 Designated
334 4-9-(3S)-tetrahydro-3-furanyl-8-(2,4,6-trifluorophenyl)amino-9H-purin-2-ylamino-trans-cyclohexanol Treatment of idiopathic pulmonary fibrosis 09/23/2011 Designated/Withdrawn
335 4-4-(4-Chlorophenoxy)phenylsulfonyl-methyl tetrahydro-N-hydroxy-2H-pyran-4-carboxamide Prophylaxis of organ rejection in patients receiving allogeneic liver transplants 06/18/2008 Designated/Withdrawn
336 [[4-{(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl-amino}-3-methoxy-benzoic acid]] Treatment of Acute Myeloid Leukemia 05/19/2014 Designated
337 [[4-{4-Amino-3-(4-cyclohexylpiperazin-1-yl)-9,10-dioxo-9,10-dihydroanthracen-1-ylamino}benzoic acid]] Treatment of pancreatic cancer 04/11/2018 Designated
338 4”-(p-fluorobenzyl)tylosin A Treatment of lymphatic filariasis 06/06/2017 Designated
339 4”-(p-fluorobenzyl)tylosin A Treatment of onchocerciasis 06/08/2017 Designated
340 5'-CTATCTGUC*G1TTCTCTGU-3'.17 Na+ Treatment of diffuse large B-cell lymphoma. 03/31/2015 Designated
341 5'-GCCATGGTTTTTTCTCAGG-3' Prophylaxis for patients following documented or suspected exposure to ebolavirus 10/31/2012 Designated/Withdrawn
342 5'-O-(trans-9"-octadecenoyl)-1-beta-D-2'deoxy-2',2'-difluorocytidine Treatment of pancreatic cancer 12/07/2009 Designated/Withdrawn
343 5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin Treatment of osteosarcoma (bone cancer) 06/15/2007 Designated
344 5,12-Naphthacenedione, 10-3-amino-2,3,6-trideoxy-4-O-(phenylmethyl)-a-L-lyxo-hexopyranosyloxy-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)- (9CI) Treatment of malignant gliomas 10/11/2006 Designated/Withdrawn
345 5,5',5"-Phosphinothioylidyne-tris(imino-2,1-ethanediyl)tris5-methylchelidoniniumtrihydroide hexahydrochloride Treatment of pancreatic cancer 08/20/2003 Designated
346 5,5-dimethyl-3-2-(7-methylspiro2H-benzofuran-3,1'-cyclopropane-4-yl)oxypyrimidin-5-ylimidazolidine-2,4-dione Treatment of fragile X syndrome 06/12/2017 Designated
347 5,6-dihydro-5-azacytidine Treatment of malignant mesothelioma. 05/11/1992 Designated
348 5,7-Dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)-one mesylate Treatment of multiple system atrophy 01/29/2019 Designated
349 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride Treatment of Huntington's disease 09/04/2014 Designated/Withdrawn
350 5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one Prevention of acute radiation syndrome 06/18/2007 Designated
351 5-((4-(6-chlorothieno2,3-dpyrimidine-4-ylamino)piperidin-1-yl)methyl)-2-fluorobenzonitrile monofumurate Treatment of pulmonary arterial hypertension 10/21/2010 Designated/Withdrawn
352 5-(3,5-Dimethyl-4-hydroxybenzylamino)-3-(4-morpholin-4-yl-phenylamino)-1H-pyrazole-4-carboxylic acid amide Treatment of Idiopathic Pulmonary Fibrosis 12/07/2018 Designated
353 5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium chloride Treatment of Dercum’s disease (adiposis dolorosa) 11/21/2019 Designated
354 5-(3-ethyl-1,2,4-oxadiazol-5-yl)-1,4,5,6-tetrahydropyrimidine hydrochloride Treatment of progressive supranuclear palsy. 04/18/2011 Designated
355 5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)-pyridin-2-amine Treatment of primary central nervous system lymphoma. 11/21/2016 Designated
356 5-(4-((2S,5S)-5-(4-chlorobenzyl)-2-methylmorpholino)piperidin-1-yl)-1H-1,2,4-triazol-3-amine Treatment of idiopathic pulmonary fibrosis 02/25/2019 Designated
357 5-(4-((2S,5S)-5-(4-chlorobenzyl)-2-methylmorpholino)piperidin-1-yl)-1H-1,2,4-triazol-3-amine Treatment of sarcoidosis 01/14/2020 Designated
358 5-(4-carboxymethyl-phenylazo)-2-hydroxybenzoic acid disodium salt Treatment of pediatric ulcerative colitis (UC) 08/31/2017 Designated
359 5-(4-Cyclopropyl-1H-imidazol-l-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridin-2-yl)-4-methylbenzamide Treatment pulmonary arterial hypertension 01/15/2015 Designated
360 5-(6,6-dimethyl-4-morpholino-8,9-dihydro-6H-1,4oxazino3,4-epurin-2-yl)pyrimidin-2-amine Treatment of glioblastoma multiforme (GBM) 02/21/2018 Designated
361 5-(ethylsulfonyl)-2-(naphthalen-2-yl)benzpdoxazole Treatment of Duchenne Muscular Dystrophy 11/22/2011 Designated
362 5-aminolevulinic acid Visualization of malignant tissue during surgery for malignant glioma (WHO grades III and IV) 01/15/2013 Designated/Approved
363 5-aza-2'-deoxycytidine Treatment of acute leukemia. 08/03/1987 Designated
364 5-aza-2'-dexocytidine combined with 1-(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl-4-hydroxy-1,3-diazinan-2-one Treatment of thalassemia 02/16/2017 Designated
365 5-Chloro-N-(3-cyclopropyl-5-(((3R,5S)-3,5-dimethylpiperazine-1-yl)methyl)phenyl)-4-(6-methyl-1H-indol-3-yl)pyrimidin-2-amine·monohydrate Treatment of Acute Myeloid Leukemia 10/25/2018 Designated
366 5-cholesten-3ß, 25-diol 3-sulfate sodium salt (25HC3S) Treatment of primary sclerosing cholangitis (PSC) 07/06/2017 Designated
367 5-fluoro-2-(6-fluoro-2-methyl-1H-benzodimidazole-1-yl)-N4-(4-(trifluoromethyl)phenyl)pyrimidine-4,6-diamine Treatment of soft tissue sarcoma 02/13/2020 Designated
368 5-hydroxymethyl-2-furfuraldehyde Treatment of sickle cell disease 05/26/2006 Designated
369 5-imino-13-deoxydoxorubicin HCl Treatment of soft tissue sarcoma 12/31/2015 Designated
370 5-iodo-2-pyrimidinone-2'-deoxyribose Treatment of malginant glioma 05/26/2006 Designated
371 5-iodo-2-pyrimidinone-2’deoxyribose Treatment of glioblastoma 06/25/2019 Designated
372 5-(E)-2-(4-hydroxyphenyl)-ethenyl benzene-1,3 diol Treatment of MELAS syndrome 03/13/2008 Designated
373 5-1-(2,6-Dichlorobenzyl)-piperidin-4-ylmethoxyquinazoline-2,4-diamine Treatment of spinal muscular atrophy 08/25/2009 Designated/Withdrawn
374 5-8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6yl-2-pyrimidinamine Treatment of malignant mesothelioma 02/10/2015 Designated/Withdrawn
375 [[5-{(1R,2R)-2-(Cyclopropylmethyl)aminocyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride]] Treatment of Kabuki Syndrome 04/26/2018 Designated
376 [[5-{(3R,4R)-1-(4-chloro-2,6-difluorophenyl)-3,4-dihydroxypiperidin-4-ylmethoxy}-8-fluoro-3,4-dihydroquinolin-2(1H)-one]] Treatment of active tuberculosis 12/05/2016 Designated
377 5a8, monoclonal antibody to CD4 For use in post-exposure prophylaxis for occupational exposure to human immunodeficiency virus. 12/20/1993 Designated/Withdrawn
378 5’-cEtG-sp-cEt5MeU-sp-cEt5MeU-sp-dT-sp-dA-sp-dT-sp-dT-sp-dA-sp-dT-sp-dA-sp-dG-sp-dG-sp-dG-sp-cEt5MeC-sp-cEt5MeU-sp-cEt5MeU-3’ Treatment of centronuclear myopathies 08/05/2019 Designated
379 5ÿ¿ÿÿÿ¢ÿ¿ÿÿ¬"-GAATATTAACAIACTGACAAGTC-3ÿ¿ÿÿÿ¢ÿ¿ÿÿ¬" Prophylaxis following documented or suspected exposure to marburg virus 10/31/2012 Designated/Withdrawn
380 6'-((6-aminopyrimidin-4-yl)amino)-8'-methyl-2'H-spirocyclohexane-1,3'-imidazo1,5apyridine-1',5'-dione hydrochloride Treatment of diffuse large B-cell lymphoma 02/23/2017 Designated
381 6'-(R)-Methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)- paromamine sulfate Treatment of Rett syndrome 11/03/2016 Designated
382 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate Treatment of Cystinosis 04/26/2018 Designated
383 6,8-bis(benzylthio)octanoic acid Treatment of Peripheral T-cell Lymphoma (PTCL) 02/28/2018 Designated
384 6,8-bis(benzylthio)octanoic acid Treatment of Burkitt’s Lymphoma (BL) 01/25/2018 Designated
385 6,8-bis-benzylsulfanyl-octanoic acid Treatment of myelodysplastic syndrome 09/26/2013 Designated
386 6,8-bis-benzylsulfanyl-octanoic acid Treatment of pancreatic cancer 02/06/2006 Designated
387 6,8-bis-benzylsulfanyl-octanoic acid Treatment of acute myeloid leukemia. 08/22/2011 Designated
388 6-((3S,4S)-4-Methyl-1-pyrimidin-2-ylmethyl-pyrrolidin-3-yl-1-(tetrahydro-pyran-4-yl)-1,5-dihydro-pryazolo3,4-dpyrimidin-4-one Treatment of sickle cell disease 09/04/2014 Designated
389 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo3.1.1heptan-3-yl)pyridin-3-yl)pyrazolo1,5-apyridine-3-carbonitrile Treatment of pancreatic cancer. 10/10/2018 Designated
390 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzob1,4oxazin-3(4H)-one hydrochloride Treatment of pulmonary arterial hypertension (WHO Group 1) 11/09/2016 Designated
391 6-(4-(4-(2,3-Dicholorophenyl) piperazin-1-yl) butoxy)-2H-benzo b 1,4 oxazin-3(4H)-one hydrochloride Treatment of Idiopathic Pulmonary Fibrosis 04/04/2018 Designated
392 6-(R)-Methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)- paromamine sulfate Treatment of mucopolysaccharidosis type 1 (MPS I) 10/18/2016 Designated
393 6-alpha-ethylchenodeoxycholic acid Treatment of primary sclerosing cholangitis 04/09/2008 Designated
394 6-amino-5-chloro-N-1R)-1-5-5-hloro-4-(trifluoromethyl)-2pyridinylaminocarbonyl-2-thiazoylethyl-4-pyrimdinecarboxamide Treatment of stage IIb-IV melanoma 10/15/2013 Designated
395 6-Amino-9-(3R)-1-(but-2-ynoyl)pyrrolidin-3-yl-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one monohydrochloride Treatment of chronic lymphocytic leukemia. 06/05/2017 Designated
396 6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-bensoxazin-4-one Treatment of Netherton syndrome 06/18/2015 Designated
397 6-fluoro-(18F)-L-3,4-dihydroxyphenylalanine A diagnostic for management of patients with Lesch-Nyhan syndrome 09/07/2016 Designated
398 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-4-methyl-2-(propan-2-yl)pyridin-3-yl-4-(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-ylpyrido2,3-dpyrimidin-2(1H)-one Treatment of KRAS (Kirsten rat sarcoma viral oncogene homolog) p.G12C-positive Colorectal Cancer. 05/23/2019 Designated
399 6-hydroxymethylacylfulvene Treatment of histologically confirmed advanced or metastatic pancreatic cancer. 04/06/1999 Designated/Withdrawn
400 6-mercaptopurine oral liquid Treatment of acute lymphoblastic leukemia in the pediatric population 12/07/2009 Designated
401 6-methoxy-3-(3',4',5'-trimethoxybenzoyl) indole Treatment of cholangiocarcinoma 05/11/2016 Designated
402 6-(3S,4S-4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl-3-tetrahydropyran-4-yl-7H-imadazo1,5-apyrazin-8-one Treatment of sickle cell disease (SCD) 01/31/2017 Designated
403 6-18F fluoro-L-m-tyrosine Diagnostic for the management of Aromatic L-Amino Acid Decarboxylase Deficiency 04/17/2019 Designated
404 6-4-Deoxy-4-(2E,4E)-tetradecadienoylglycylamino-L-glycero-B-L-manno-heptopyranosylamino-9H-purine Treatment of multiple myeloma 06/12/2014 Designated/Withdrawn
405 [[6-{4-l-(propan-2-yl)piperidin-4-yl-1,4-diazepan-1-yl}-N-(pyridin-4-yl)pyridine-2-carboxamide]] Treatment of glioblastoma multiforme (GBM). 02/11/2016 Designated
406 [[6-{(1R,2S)-2-aminocyclohexylamino-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo3,4-cpyridin-3-one monocitrate]] Treatment of follicular lymphoma 02/25/2019 Designated
407 [[6-{(1R,2S)-2-aminocyclohexylamino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo3,4-cpyridin-3-one monocitrate]] Treatment of acute myeloid leukemia (AML) 10/03/2017 Designated
408 [[6-{(1R,2S)-2-aminocyclohexylamino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo3,4-cpyridine-3-one monocitrate]] Treatment of diffuse large B-cell lymphoma 02/14/2017 Designated
409 [[6-{(1S)-1-phenylethylamino}-3-(propan-2-yl)-1,2,3,4 tetrahydropyrimidine-2,4-dione]] Treatment of symptomatic obstructive hypertrophic cardiomyopathy 04/27/2016 Designated
410 7,8-dibromo-5,6-dihydro-9-methyl-2-(1-piperazinyl)-4H-imidazo4,5,1-ij quinoline hydrochloride Treatment of acute myeloid leukemia 03/26/2020 Designated
411 7-(4-fluoro-2-methoxyphenyl)-6-methyl-N-(1-(piperidin-4-yl)-1H-pyrazol-4-yl) thieno 3,2-dpyrimidin-2-amine semi-fumarate Treatment of acute myeloid leukemia 03/26/2018 Designated
412 7-B-Hydroxy Cholesteryl-3-B-Oleate-Ester Treatment of gliomas. 06/15/2011 Designated
413 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo1,2-apyrido3,4-epyrimidin-5(4H)-one Treatment of malignant glioma 06/04/2018 Designated
414 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo1,2-apyrido3,4-epyrimidin-5(4H)-one*2HCl Treatment of glioblastoma. 06/23/2016 Designated
415 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo1,2-apyrido3,4-epyrimidin-5(4H)-one-2HCL Treatment of mantle cell lymphoma (MCL) 02/07/2017 Designated
416 7-ethyl-10-hydroxycamptothecin (EHC) Treatment of small cell lung cancer. 04/13/2016 Designated
417 72 amino acid proprietary recombinant protein antagonist for the CXCR1 and CXCR2 receptors of interleukin-8 Treatment of Pancreatic Cancer 06/04/2019 Designated
418 8 Cyclopentyl 1,3-dipropylxanthine Treatment of cystic fibrosis. 03/24/1997 Designated/Withdrawn
419 8-(1-Hydroxy-ethyl)-2-methoxy-3-(4-methoxy-benzyloxy)-benzocchromen-6-one Treatment of glioblastoma multiforme 01/21/2015 Designated
420 8-(6-iodobenzo1,3dioxol-5-ylsufanyl)-9-(3-isopropylamino propyl)adenine dihydrochloride Treatment of Myelofibrosis 05/16/2018 Designated
421 8-bromo-2-(1-methylpiperidin-4-yl) amino)-4-(4-phenoxyphenyl) amino) pyrido4,3-d pyrimidin-5(6H)-one hydrochloride Treatment of Acute Myeloid Leukemia 11/20/2018 Designated
422 8-methoxsalen For use in conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis. 06/22/1993 Designated
423 8-4-(1-aminocyclobutyl)phenyl-9-phenyl-1,2,4-triazolo3,4-f1,6naph-thyrin-3(2H)-one mono-hydrochloride Treatment of ovarian cancer. 09/03/2009 Designated
424 9,10-dimethoxy-5,6-dihydro-1,3 dioxolo4,5-gisoquinolino3,2-alphaisoquinolin-7-ium(R)-4-((3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyhexadecahydro-1H-cyclopentaalpha Treatment of primary sclerosing cholangitis 08/29/2016 Designated
425 9-cis, 12-cis-11,11-d2-linoleic acid ethyl ester Treatment of Friedreich's Ataxia 05/23/2016 Designated
426 9-cis,12-cis-11,11-D2-linoleic acid ethyl ester Treatment of PLA2G6-associated neurodegeneration 10/24/2017 Designated
427 9-cis-retinoic acid Prevention of retinal detachment due to proliferative vitreoretinopathy. 01/02/1997 Designated/Withdrawn
428 9-nitro-20-(S)-camptothecin Treatment of pancreatic cancer. 09/16/1996 Designated
429 9-nitro-20-(S)-camptothecin Treatment of pediatric HIV infection/AIDS 05/15/2001 Designated
430 90Y-DOTA-tyr3-Octreotide Treatment of neuroendocrine tumors 01/20/2016 Designated
431 90Y-hPAMA4 Treatment of pancreatic cancer 01/29/2004 Designated/Withdrawn
432 99mTc-HYNIC-D-Phe1,Tyr3-Octreotide trifluoroacetate Diagnostic for the management of neuroendocrine tumors 12/05/2018 Designated
433 A cellular product consisting of autologous CD34+ human hematopoietic stem and progenitor cells modified by clustered regularly interspaced short palindromic repeats-associated 9 nuclease (CRISPR-Cas9)-mediated gene editing Treatment of ß-thalassemia 04/28/2020 Designated
434 A cellular product consisting of autologous CD34+ human hematopoietic stem and progenitor cells modified by CRISPR-Cas9-mediated gene editing Treatment of sickle cell disease 05/11/2020 Designated
435 a live attenuated bioengineered Listeria monocytogenes cancer immunotherapy Treatment of Stage II to IV invasive cervical carcinoma 04/29/2014 Designated
436 a long-acting interleukin-11 analog comprised of 178 amino acids covalently modified wiht a 40-kDa branched maleimide-polyethylene glycol at the added cysteine residue following the carboxy-terminal amino acid Treatment of acute radiation syndrome 04/17/2019 Designated
437 a non-replicating, recombinant adeno-associated virus serotype 9 (AAV9) containing the human Methyl CpG Binding Protein 2B (MECP2B) cDNA under the control of a segment of the murine MECP2 promoter. Treatment of Rett Syndrome (RTT) 04/17/2019 Designated
438 A potent and selective inhibitor of Gamma Secretase-mediated NOTCH signaling Treatment of Adenoid cystic carcinoma 05/08/2019 Designated
439 a recombinant adeno-associated virus pseudotyped with serotype 5 viral capsid encoding CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats associated protein 9) gene editing constructs Treatment of CEP290 gene mutations including Leber congenital amaurosis. 07/23/2019 Designated
440 A recombinant humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 Treatment of Nasopharyngeal carcinoma 02/13/2020 Designated
441 A replication-incompetent, non-integrating Herpes simplex type 1 (HSV-1) vector expressing the human transglutaminase-1 (TGM-1) enzyme Treatment of TGM-1-deficient autosomal recessive congenital ichthyosis (ARCI) 08/07/2018 Designated
442 a self-complementary adeno-associated virus serotype 9 expressing human codon-optimized CLN1 under control of CBh Treatment of neuronal ceroid lipofuscinosis type 1 (CLN1) 02/07/2018 Designated
443 A small molecule inhibitor of the pro-survival protein Myeloid Cell Leukemia sequence 1 (MCL 1) Treatment of Acute Myeloid Leukemia 02/15/2019 Designated
444 a small molecule tissue-nonspecific alkaline phosphatase inhibitor Treatment of Pseudoxanthoma elasticum 10/07/2019 Designated
445 a strain of modified live probiotic bacterium Escherichia coli (E.coli) Nissle 1917 that has been modified to treat phenylketonuria by consuming phenylalanine within the gastrointestinal tract Treatment of phenylketonuria (PKU) 10/18/2017 Designated
446 a synthetic double-stranded RNA oligonucleotide conjugated to N-acetyl-D-galactosamine aminosugar residues Treatment of alpha-1 antitrypsin deficiency 03/16/2020 Designated
447 a Toll-like receptor (TLR) 9 agonist Treatment of Stage IIb to IV Melanoma 02/26/2020 Designated
448 A-dmDT390-bisFv(UCHT1) Treatment of cutaneous T-cell lymphoma 10/09/2014 Designated
449 a-Galactosidase A Treatment of Fabry's disease 01/21/2003 Designated
450 A10 & AS2-1 Antineoplaston Treatment for patients with brain stem glioma 09/03/2004 Designated
451 aadeno-associated viral vector, serotype 2, containing the human choroideremia gene encoding human Rab escort protein 1 Treatment of choroideremia due to mutations in the human choroideremia gene (CHM) 09/12/2013 Designated
452 AAV-G6Pase vector Treatment of glycogen storage disease type Ia 03/11/2013 Designated
453 abagovomab Treatment of epithelial ovarian cancer 11/25/2003 Designated/Withdrawn
454 abatacept Treatment of type 1 diabetes mellitus patients with residual beta cell function 05/30/2013 Designated
455 Abatacept Treatment of giant cell arteritis 02/22/2017 Designated
456 abatacept Prevention of Graft versus Host Disease 12/26/2017 Designated
457 abatacept Treatment of idiopathic inflammatory myopathy (IIM) 02/22/2017 Designated
458 ABCA4 DNA nanoparticles Treatment of Stargardt Macular Degeneration 10/28/2015 Designated
459 abeotaxane inhibitor of microtubules Treatment of pediatric neuroblastoma. 04/18/2011 Designated
460 abeotaxane inhibitor of microtubules Treatment of gliomas 10/07/2011 Designated
461 Abetimus Treatment of lupus nephritis. 07/28/2000 Designated
462 Ac-225-4-PHenylbutyryl-His-D-Phe-Arg-Trp-Gly-Lys(eAhx-DOTA)-NH2 Treatment of Uveal Melanoma 02/28/2019 Designated
463 Ac-Ile-Cys-Val-Trp(1-Me)-Gln-Asp-Trp-Gly-Ala-His-Arg-Cys-Thr-AEEA-Lys-PEG 40KDa-Lys-AEEA-Thr-Cys-Arg-His-ALa-Gly-Trp-Asp-Gln-(1-Me)Trp-Val-Cys-Ile-Ac Treatment of paroxysmal nocturnal hemoglobinuria 04/20/2014 Designated
464 Ac-Nle-cyclo-(Glu-His-D-Phe-Arg-Dap)-Trp-NH2 Treatment of non-infectious intermediate, posterior, pan, and chronic anterior uveitis 06/03/2019 Designated
465 acadesine Treatment of multiple myeloma 05/04/2011 Designated
466 acadesine Treatment of chronic lymphocytic leukemia 03/03/2011 Designated
467 acalabrutinib Treatment of Waldenstrom macroglobulinemia. 10/22/2015 Designated
468 acalabrutinib Treatment of mantle cell lymphoma. 09/21/2015 Designated/Approved
469 acalabrutinib Treatment of chronic lymphocytic leukemia (CLL). 05/13/2015 Designated/Approved
470 acamprosate Treatment of fragile X syndrome 03/25/2013 Designated
471 aceneuramic acid Treatment of hereditary inclusion body myopathy 09/23/2011 Designated/Withdrawn
472 acetic acid, propionic acid, and butyric acid Treatment of Hepatocellular Carcinoma 10/22/2019 Designated
473 acetyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-cysteinyl-D-glutaminyl-D-cystenyl-D-arginyl-D-arginyl-D-lysyl-D-asparaginylmaide disulfide Treatment of acute myeloid leukemia. 11/24/2015 Designated
474 acetyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-cysteinyl-D-glutaminyl-D-cysteinyl-D-arginyl-D-arginyl-D-lysyl-Dasparaginylamide disulfide Treatment of pancreatic cancer. 02/18/2011 Designated/Withdrawn
475 acetyl-l-carnitine Treatment of Fragile X syndrome 07/24/2012 Designated/Withdrawn
476 acetyl-l-carnitine (ALC) Treatment of Rett syndrome 03/18/2011 Designated/Withdrawn
477 Acetylcysteine Intravenous treatment of patients presenting with moderate to severe acetaminophen overdose. 08/13/1987 Designated
478 acetylcysteine For the intravenous treatment of moderate to severe acetaminophen overdose 10/19/2001 Designated/Approved
479 acetylcysteine effervescent tablets for oral solution Preventing hepatic injury from acetaminophin overdose 02/24/2015 Designated/Approved
480 Aconiazide Treatment of tuberculosis. 06/20/1988 Designated/Withdrawn
481 activated natural killeraNK) Treatment of Merkel cell carcinoma 03/15/2017 Designated
482 Active calcium sensing receptor antagonist derived from tetrahydropyrazolopyrimidine Treatment of pulmonary arterial hypertension 06/13/2017 Designated
483 ActRIIB-IgG1) Treatment of Duchenne muscular dystrophy 08/16/2010 Designated/Withdrawn
484 acyclovir Treatment of herpetic keratitis 09/16/2010 Designated/Withdrawn
485 acyclovir Treatment of herpetic keratitis. 05/03/2016 Designated
486 acyclovir Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2 12/13/2010 Designated/Approved
487 Ad5/3-D24-granulocyte-macrophage colony stimulating factor (GMCSF)-encoding oncolytic adenovirus Treatment of ovarian cancer 03/17/2014 Designated
488 adalimumab Treatment of Behcet's disease 07/10/2014 Designated
489 adalimumab Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) 05/13/2015 Designated/Approved
490 adalimumab Treatment of pediatric Crohn's disease 10/19/2006 Designated/Approved
491 adalimumab Treatment of juvenile rheumatoid arthritis 03/21/2005 Designated/Approved
492 adalimumab Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis 05/13/2014 Designated/Approved
493 adalimumab Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis 05/13/2014 Designated/Approved
494 adalimumab Treatment of pediatric patients with ulcerative colitis 05/11/2011 Designated
495 adalimumab Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) 05/13/2015 Designated/Approved
496 adalimumab Treatment of juvenile rheumatoid arthritis 03/21/2005 Designated/Approved
497 aden-associated virus vector serotype 9 expressing human a-L-iduronidase Treatment of mucopolysaccharidosis Type I (MSP I). 09/29/2015 Designated
498 adeno associated viral vector containing human ARSB gene Treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy syndrome) 03/17/2011 Designated
499 adeno associated viral vector containing Padua derivative of the human coagulation factor IX cDNA Treatment of Hemophilia B 04/17/2019 Designated
500 adeno associated viral vector serotype rh.10 carrying the human SGSH and SUMF1 cDNAs Treatment of mucopolysaccharidosis type IIIA (Sanfilippo type A syndrome) 05/06/2013 Designated
501 Adeno Associated Virus carried Multi Characteristic Opsin Treatment of retinitis pigmentosa 10/03/2017 Designated
502 Adeno Associated Virus Serotype 8 Encoding the Collagen Q Gene Treatment of Collagen Q Congenital Myasthenia 02/24/2020 Designated
503 adeno associated virus with modified transthyretin and sequence encoding factor IX variant gene Treatment of hemophilia B 03/14/2014 Designated
504 Adeno-associated vector expressing the human lipoprotein lipase protein Treatment of lipoprotein lipase deficiency 05/21/2007 Designated/Withdrawn
505 adeno-associated viral (AAV) vector serotype rh. 10 encoding the human N-sulfoglycosamine sulphohydrolase cDNA (SGSH) Treatment of mucopolysaccharidosis type IIIA or Sanfilippo type A syndrome 11/18/2015 Designated
506 adeno-associated viral serotype 2 vector under the regulatory control of a CMV promoter encoding the human tripeptidyl peptidase-1 (hTPP1) cDNA Treatment of CLN2 disease (neuronal ceroid lipofuscinosis (NCL)) caused by TPP1 deficiency. 03/16/2016 Designated
507 adeno-associated viral vector 9-containing the human heparan-alpha-glucosaminide N-acetyltransferase (HGSNAT) gene (AAV9- HGSNAT) Treatment of Sanfilippo Syndrome IIIC (also known as Mucopolysaccharidosis IIIC/MPS IIIC) 01/16/2019 Designated
508 adeno-associated viral vector composed of a bioengineered AAV capsid and a codon-optimized expression cassette encoding a high-specific activity variant of human coagulation factor IX Treatment of hemophilia B. 09/21/2015 Designated
509 adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin in combination with an adeno-associated viral vector containing DNA encoding a rhodopsin gene treatment of retinitis pigmentosa 12/13/2012 Designated
510 adeno-associated viral vector containing modified U11 snRNA Treatment of Duchenne muscular dystrophy. 09/15/2010 Designated
511 Adeno-associated viral vector containing the gene for human coagulation factor IX Intramuscular treatment of patients with moderate to severe hemophilia 06/13/2001 Designated
512 Adeno-associated viral vector containing the gene for human coagulation factor IX Intrahepatic treatment of patients with moderate to severe hemophilia 06/13/2001 Designated
513 Adeno-associated viral vector differentially expressing microdystrophin 5 gene via the muscle-specific promoter CK8 (rAAV9-CK8-h-µD5) Treatment of Duchenne muscular dystrophy 08/31/2016 Designated
514 Adeno-Associated Viral Vector encoding C1 Esterase Inhibitor Treatment of Angioedema due to C1-Inhibitor Deficiency 08/22/2018 Designated
515 Adeno-associated viral vector encoding human multidrug resistance protein 3A (MDR3A) Treatment of progressive familial intrahepatic cholestasis 03/16/2020 Designated
516 Adeno-associated viral vector expressing human acid alpha glucosidase gene Treatment of Pompe disease 03/20/2007 Designated
517 adeno-associated viral vector expressing human retinoschisin-1 gene Treatment of X-linked juvenile retinoschisis (XLRS). 05/21/2007 Designated
518 Adeno-Associated Viral Vector Expressing Low-Density Lipoprotein Receptor Treatment of homozygous familial hypercholesterolemia 01/31/2012 Designated
519 adeno-associated viral vector expressing the human vascular endothelial growth factor gene Treatment of critical limb ischemia in no-option patients where other procedures, grafts, or angioplasty are not indicated 12/31/2015 Designated
520 adeno-associated viral vector serotype 2 containing the human Rab escort protein 1 gene Treatment of choroideremia 11/05/2014 Designated
521 adeno-associated viral vector serotype 2.7m8 containing the chrimsonR-tdTomato gene Treatment of retinitis pigmentosa 01/25/2017 Designated
522 adeno-associated viral vector serotype 3B encoding shortened human ATP7B Treatment of Wilson's disease 09/07/2017 Designated
523 Adeno-associated viral vector serotype 5 containing human ABCA4 gene Treatment of Stargardt's disease. 09/30/2008 Designated/Withdrawn
524 adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene Treatment of Huntington's disease 09/27/2017 Designated
525 Adeno-associated viral vector serotype 8 containing cDNA of the human PDE6A protein Treatment of Retinitis Pigmentosa 03/09/2020 Designated
526 Adeno-associated viral vector serotype 8 containing the human RPGR gene Treatment of inherited retinal dystrophies due to defects in the RPGR gene 09/27/2018 Designated
527 adeno-associated viral vector serotype 9 containing human N-acetylglucosaminidase alpha gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome) 12/27/2012 Designated
528 adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene Treatment of catecholaminergic polymorphic ventricular tachycardia 10/02/2014 Designated
529 Adeno-associated viral-based vector cystic fibrosis gene therapy Treatment of cystic fibrosis. 02/15/1995 Designated/Withdrawn
530 adeno-associated virus (AAV) serotype rh.10 expressing beta-galactosidase Treatment of GM1 gangliosidosis 01/30/2017 Designated
531 adeno-associated virus (AAV2) capsid variant carrying a transgene encoding a codon-optimized human choroideremia (CHM) gene Treatment of choroideremia (CHM) 10/12/2017 Designated
532 Adeno-Associated Virus containing the gene for human Nuclear Hormone Receptor NR2E3 (AAV-hNR2E3) Treatment of CEP290 mutation associated retinal disease. 08/20/2019 Designated
533 Adeno-associated virus delivered transgene of follistatin Treatment of inclusion body myositis 09/19/2016 Designated
534 Adeno-Associated Virus Serotype 2 capsid variant (4D-C102) carrying a transgene encoding a codon-optimized human alpha-galactosidase A gene Treatment of Fabry Disease 03/09/2020 Designated
535 Adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and human factor 9 gene (SB-FIX) Treatment of hemophilia B 09/01/2016 Designated
536 adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and the human alpha-L-iduronidase (hIDUA) gene Treatment of mucopolysaccharidosis type I (MPS I) 01/09/2017 Designated
537 Adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and the human iduronate 2-sulfatase (hIDS) gene Treatment of mucopolysaccharidosis type II 02/27/2017 Designated
538 adeno-associated virus serotype 2/6 encoding a human alpha-galactosidase A cDNA Treatment of Fabry Disease 10/21/2019 Designated
539 adeno-associated virus serotype 5 capsid containing the gene for human Nuclear Hormone Receptor NR2E3 Treatment of NR2E3 mutation-associated retinal degenerative disease 02/08/2019 Designated
540 adeno-associated virus serotype 6 containing human LAMAN cDNA Treatment of alpha-mannosidosis 02/15/2018 Designated
541 Adeno-associated virus serotype 8 vector expressing B domain deleted codon optimized factor VIII Treatment of hemophilia A 09/18/2017 Designated
542 adeno-associated virus serotype 9 vector containing human Iduronate-2-sulfatase transgene Treatment of mucopolysaccharidosis type II (Hunter syndrome). 07/16/2015 Designated
543 Adeno-associated virus serotype 9 vector containing human Nacetylgalactosamine-6-sulfate sulfatase gene Treatment of mucopolysaccharidosis type IVA (Morquio A Syndrome) 01/15/2020 Designated
544 Adeno-associated virus serotype 9 vector containing the human lysosome-associated membrane glycoprotein 2 isoform B transgene (AAV9.LAMP2B) Treatment of Danon Disease 02/01/2019 Designated
545 Adeno-associated virus serotype 9 vector encoding the Dok7 protein Treatment of Dok7 Myasthenia 01/23/2020 Designated
546 Adeno-associated virus serotype 9 vector with engineered transgene encoding the human CLN5 gene Treatment of neuronal ceroid lipofuscinosis type 5 06/03/2020 Designated
547 adeno-associated virus serotype rh10 encoding artificial anti-SOD1 miRNA Treatment of Amyotrophic Lateral Sclerosis 06/11/2019 Designated
548 Adeno-associated virus serotype rh10 vector encoding the human factor IX gene Treatment of hemophilia B. 08/25/2015 Designated
549 adeno-associated virus transgene of follistatin Treatment of Duchennes and Becker's muscular dystrophy 11/19/2012 Designated
550 adeno-associated virus type 2 encoding human aromatic L-amino acid decarboxylase Treatment of aromatic L-amino acid decarboxylase deficiency 11/14/2017 Designated
551 adeno-associated virus type 8 delivering a vector genome with human retinoschisin promoter (RS/IRBP) and the human retinoschisin cDNA (hRS) Treatment of X-linked retinoschisis 11/16/2015 Designated
552 adeno-associated virus vector encoding human phenylalanine hydroxylase Treatment of phenylketonuria 10/21/2019 Designated
553 adeno-associated virus vector encoding the SQ variant of human blood clotting factor VIII Treatment of Hemophilia A. 02/29/2016 Designated
554 adeno-associated virus vector expressing human 21-hydroxylase Treatment of congenital adrenal hyperplasia 21-hydroxylase deficiency 08/30/2018 Designated
555 adeno-associated virus vector serotype 9 expressing human sulfamidase Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A Syndrome). 06/01/2011 Designated
556 Adenoassociated virus vector (AAV) carrying a modified AAV serotype 2 backbone and coding sequence of human thymidine phosphorylase preceded by a human thyroxin-binding globulin promoter For the treatment of Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE) 09/04/2014 Designated
557 Adenosine For use in conjunction with BCNU in the treatment of brain tumors. 08/01/1989 Designated/Withdrawn
558 Adenosine triphosphate type 1 competitive inhibitor of JAK2 V617F tyrosine kinase Treatment of myeloproliferative disorders (polycythemia vera, essential throbocythemia, and myelofibrosis) 03/03/2011 Designated
559 Adenoviral vector expressing Herpes simplex virus thymidine kinase gene Treatment of malignant brain tumors 06/17/2005 Designated
560 adenoviral vector expressing the E.coli purine nucleoside phosphorylase gene and fludarabine Intratumoral treatment of anatomically accessible oral and pharyngeal cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity) 06/08/2015 Designated
561 Adenoviral vector-RheoSwitch Therapeutic System-human interleukin 12 + veledimex Treatment of malignant glioma. 07/23/2015 Designated
562 adenovirus associated viral vector serotype 5 containing the human RPE65 gene Treatment of Leber congenital amaurosis 03/10/2016 Designated
563 adenovirus associated viral vector serotype 5 containing the RPGR gene Treatment of retinitis pigmentosa 11/29/2016 Designated
564 adenovirus associated viral vector serotype 8 containing the human AIPL1 gene Treatment of inherited retinal dystrophy due to defects in AIPL1 gene, including Leber congenital amaurosis, retinitis pigmentosa, and cone-rod dystrophy 02/01/2018 Designated
565 adenovirus associated viral vector serotype 8 containing the human CNGB3 gene Treatment of achromatopsia due to mutations in the CNGB3 gene. 03/10/2016 Designated
566 adenovirus associated viral vector serotype 8 containing the human Cyclic Nucleotide Gated Channel Alpha 3 subunit (CNGA3) gene Treatment of achromatopsia due to CNGA3 gene mutations. 08/07/2018 Designated
567 adenovirus containing a human FAS-c gene Treatment of malignant glioma 04/02/2012 Designated
568 adenovirus delta 24-RGD, an oncolytic adenovirus genetically modified for treatment of glioma Treatment of glioma 10/01/2014 Designated
569 Adenovirus encoding the recombinant CD40 ligand Treatment of stage IIb through IV melanoma. 04/19/2016 Designated
570 Adenovirus serotype-5 (Ad5) vector that contains a modified non-oncogenic fused early 6 (E6) and early 7 (E7) gene of the human papillomavirus (HPV); (Ad5 E1-, E2b--E6/E7) Treatment of human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) 09/04/2014 Designated
571 adenovirus vaccine encoding reduced expression in immortalized cell protein Treatment of mesothelioma 07/14/2015 Designated
572 adenovirus-associated viral vector serotype 5 containing the human pde6B gene Treatment of retinitis pigmentosa due to pde6B gene mutations 07/05/2016 Designated
573 adenovirus-associated viral vector serotype 5 containing the human RLBP1 gene Treatment of retinitis punctata albescens due to RLBP1 gene mutation 06/12/2017 Designated
574 Adenovirus-based vector Factor VIII complementary DNA to somatic cells Treatment of hemophilia A. 12/15/1999 Designated
575 ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS; HLA class I/II binding tumor associated peptides Treatment of renal cell carcinoma in HLA-A*2 positive patients 09/28/2012 Designated/Withdrawn
576 adipose-derived mesenchymal stem cells in a hydrogel sheet Treatment of Epidermolysis Bullosa 10/25/2018 Designated
577 adoptive, anti-FLT3 chimeric antigen receptor T cell therapy generated through transduction of autologous T-cells with a self-inactivating human immunodeficiency virus-1 based lentiviral vector Treatment of acute myeloid leukemia 06/13/2019 Designated
578 adult adherent bone marrow-derived multipotent stem cells Treatment of MPS-1, including Hurler syndrome 07/06/2012 Designated
579 adult hemogenic endothelial cells Treatment of aplastic anemia 05/27/2015 Designated
580 ADXS11-001 Treatment of HPV-positive associated anal cancer 08/12/2013 Designated
581 aerosolized beractant Treatment of respiratory distress syndrome 03/11/2013 Designated
582 Aerosolized pooled immune globulin Treatment of respiratory syncytial virus lower respiratory tract disease. 01/03/1989 Designated/Withdrawn
583 AEZS-108 (LHRH-agonist linked to doxorubicin) Treatment of ovarian cancer 04/30/2010 Designated/Withdrawn
584 afamelanotide Treatment of erythropoietic porphyrias 07/17/2008 Designated/Approved
585 afamelanotide Treatment of cutaneous variants of porphyria (which includes treatment and prevention of cutaneous manifestations of disease) 02/04/2016 Designated
586 afamelanotide Treatment of solar urticaria 12/11/2009 Designated
587 afamelanotide Treatment of familial benign chronic pemphigus (Hailey-Hailey disease) 05/14/2014 Designated
588 afatinib Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). 12/03/2012 Designated/Approved
589 afatinib Treatment of pancreatic cancer 07/09/2019 Designated
590 afatinib Treatment of malignant brain and central nervous system tumors 06/04/2014 Designated
591 afatinib Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). 12/03/2012 Designated/Approved
592 afatinib Treatment of non-small cell lung cancer with squamous histology. 08/03/2015 Designated/Approved
593 aflibercept Treatment of Retinopathy of Prematurity 07/23/2019 Designated
594 aganirsen Prevention of corneal graft rejection. 11/07/2016 Designated
595 Aggregated polymer of protein magnesium ammonium phospholinoleate-palmitoleate anhydride Treatment of Schistosomiasis 02/04/2020 Designated
596 AI-RSA Treatment of autoimmune uveitis. 10/08/1992 Designated/Withdrawn
597 alanyl-glutamine dipeptide Prevention of complications associated with peritoneal dialysis (PD) treatment in end stage renal disease (ESRD) 11/06/2017 Designated
598 Albendazole Treatment of neurocysticercosis due to Taenia solium as: 1) chemotherapy of parenchymal, subarachnoidal and racemose (cysts in spinal fluid) neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and other sequelae in asymptomatic neurocysticercosis. 01/18/1996 Designated/Approved
599 Albendazole Treatment of hydatid disease (cystic echinococcosis due to E. granulosus larvae or alveolar echinococcosis due to E. multilocularis larvae). 01/17/1996 Designated/Approved
600 Albuterol Prevention of paralysis due to spinal cord injury 03/12/2002 Designated
601 Aldesleukin For the treatment non-Hodgkin's lymphoma. 11/24/1998 Designated
602 Aldesleukin Treatment of primary immunodeficiency disease associated with T-cell defects. 03/22/1989 Designated
603 Aldesleukin Treatment of metastatic melanoma. 09/10/1996 Designated/Approved
604 Aldesleukin Treatment of acute myelogenous leukemia. 07/31/1998 Designated/Withdrawn
605 Aldesleukin Treatment of metastatic renal cell carcinoma. 09/14/1988 Designated/Approved
606 aldoxorubicin Treatment of small cell lung cancer 09/24/2014 Designated
607 Aldoxorubicin Treatment of adenocarcinoma of the pancreas. 04/18/2011 Designated
608 Aldoxorubicin Treatment of soft tissue sarcoma 06/29/2011 Designated
609 aldoxorubicin Treatment of ovarian cancer 09/24/2014 Designated
610 aldoxorubicin Treatment of glioblastoma multiforme 09/24/2014 Designated
611 alectinib Treatment of ALK-positive non-small cell lung cancer 01/27/2015 Designated/Approved
612 alectinib Treatment of ALK-positive non-small cell lung cancer 01/27/2015 Designated/Approved
613 Alefacept For use as prophylaxis of rejection in patients receiving allogenic solid organ transplants. 12/19/2007 Designated/Withdrawn
614 alemtuzumab Treatment of chronic lymphocytic leukemia. 10/20/1997 Designated/Approved
615 alendronate Treatment of osteogenesis imperfecta in pediatric patients 4 years of age and older 03/31/2003 Designated/Withdrawn
616 Alendronate disodium Treatment of the bone manifestations of Gaucher disease 02/13/2001 Designated
617 Alfentanil Treatment of painful HIV-associated neuropathy 08/09/2005 Designated
618 Alfentanil Management of postherpetic neuralgia 07/08/2005 Designated
619 alfimeprase Treatment of ST-elevation myocardial infarcted patients who are undergoing primary percutaneous coronary intervention 09/20/2012 Designated
620 algenpantucel-L Treatment of pancreatic cancer. 10/21/2010 Designated/Withdrawn
621 Alglucerase injection Replacement therapy in patients with Type II and III Gaucher's disease. 07/21/1995 Designated
622 Alglucerase injection For replacement therapy in patients with Gaucher's disease type I. 03/11/1985 Designated/Approved
623 alicaforsen Treatment of pouchitis. 06/24/2008 Designated
624 alirocumab Treatment of homozygous familial hypercholesterolemia 06/15/2017 Designated
625 alisertib Treatment of small cell lung cancer 07/12/2013 Designated/Withdrawn
626 alisertib Treatment of peripheral T-cell lymphoma 05/14/2012 Designated/Withdrawn
627 Alitretinoin Treatment of AIDS-related Kaposi's sarcoma. 03/24/1998 Designated/Approved
628 Alitretinoin Treatment of acute promyelocytic leukemia 04/10/1992 Designated
629 all-cis-docosa-4,7,10,13,16,19-hexaenoic acid Treatment of retinitis pigmentosa 05/21/2014 Designated
630 allantoin Treatment of skin blistering and erosions associated with inherited epidermolysis bullosa 11/21/2002 Designated
631 allogeneic ABCB5-positive limbal stem cells Treatment of limbal stem cell deficiency 03/28/2019 Designated
632 allogeneic anti-CD19 chimeric antigen receptor (CAR)-T cells Treatment of acute lymphoblastic leukemia (ALL) 07/02/2018 Designated
633 allogeneic cardiosphere-derived cells Treatment of Duchenne Muscular Dystrophy 04/21/2015 Designated
634 Allogeneic CD3+ T lymphocytes ex vivo expanded expressing the Vgamma9Vdelta2 T-cell receptor Treatment of Acute Myeloid Leukemia 01/16/2020 Designated
635 allogeneic cord blood cells, ex vivo modulated with 16,16 dimethyl prostaglandin E2 (dmPGE2) Enhancement of stem cell engraftment through ex vivo treatment of human allogeneic hematopoietic stem cells (treatment of neuropenia, thrombocytopenia, lymphopenia, and anemia). 12/02/2010 Designated
636 Allogeneic cytomegalovirus cytotoxic T lymphocytes Treatment of cytomegalovirus viremia and disease in immunocompromised patients 08/31/2017 Designated
637 allogeneic ex vivo expanded umbilical cord blood cells For use as hematopoietic support in patients with chronic myeloid leukemia 02/01/2010 Designated/Withdrawn
638 allogeneic ex vivo expanded unbilical cord blood cells For use as hematopoietic support in patients with myelodysplastic syndromes 02/01/2010 Designated/Withdrawn
639 allogeneic ex-vivo expanded placental adherent stromal cells For the treatment of severe preeclampsia 12/29/2015 Designated
640 allogeneic ex-vivo expanded placental adherent stromal cells Treatment of thromboangiitis obliterans (Buerger's disease) 08/22/2011 Designated
641 allogeneic ex-vivo expanded placental adherent stromal cells Treatment of Aplastic Anemia 02/18/2013 Designated
642 allogeneic ex-vivo generated CD56+CD3-natural killer cells from CD34+ umbilical cord blood progenitor cells Treatment of acute myeloid leukemia 04/20/2016 Designated
643 allogeneic Fecal Microbiota Treatment of Graft-Versus-Host Disease 02/28/2018 Designated
644 Allogeneic gene edited BCMA-directed CAR T cells Treatment of multiple myeloma 12/18/2019 Designated
645 allogeneic gene edited CD20-directed CAR (Chimeric Antigen Receptor) T cells Treatment of Mantle Cell Lymphoma 09/11/2019 Designated
646 Allogeneic gene-edited CD19-directed CAR T cells/azercabtagene zapreleucel Treatment of mantle cell lymphoma 05/13/2020 Designated
647 allogeneic hematopoietic stem cell Prevention (reduction) of transplant related mortality (TRM, which is caused by graft versus host disease and/or infections) following mismatched (haploidentical) allogeneic hematopoietic stem cell transplantation. 02/02/2010 Designated
648 Allogeneic human aortic endothelial cells cultured in a porcine gelatin matrix Prevention of arteriovenous fistula or arteriovenous graft failure in patients with end satge renal disease receiving hemodialysis or preparing for hemodialysis 04/03/2009 Designated/Withdrawn
649 allogeneic human islets of Langerhans Treatment of Brittle Type 1 Diabetes 02/01/2017 Designated
650 Allogeneic Human Pancreatic Islets of Langerhans Treatment of Brittle Type 1 Diabetes 07/22/2019 Designated
651 Allogeneic Human Pancreatic Islets of Langerhans Treatment of Brittle Type 1 Diabetes 06/04/2019 Designated
652 Allogeneic human retinal pigment epithelial cells on gelatin microcarriers Treatment of Hoehn and Yahr stage 3 and 4 Parkinson's disease. 07/18/1997 Designated/Withdrawn
653 Allogeneic mesenchymoangioblast-derived mesenchymal stem cells Treatment of acute graft versus host disease 03/26/2018 Designated
654 Allogeneic motor neuron progenitor cells derived from human embryonic stem cells Treatment of Amyotrophic Lateral Sclerosis 01/17/2014 Designated/Withdrawn
655 Allogeneic multi-tumor-associated antigen-specific T cell product Treatment of acute myeloid leukemia 04/28/2020 Designated
656 Allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture Treatment of pancreatic cancer 06/13/1997 Designated
657 Allogeneic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor Treatment of retinitis pigmentosa 09/01/2004 Designated
658 allogeneic skin-derived ABCB5-positive mesenchymal stem cells Treatment of Epidermolysis Bullosa 05/01/2019 Designated
659 Allogeneic T-cells cultured with anti-CD3 and IL-2; transduced with retroviral vector (SFCMM-3), expressing herpes simplex 1 virus-thymidine kinase (HSV-TK) and truncated low affinity nerve growth factor receptor; selected with anti-low affinity nerve gro Immunotherapy for acceleration of T-cell reconstitution in patients undergoing allogeneic hematopoietic stem cell transplantation 01/28/2005 Designated
660 Allogeneic umbilical cord blood (UCB) cell therapy product consisting of two cell fractions (CD34 enriched and CD34 depleted) derived from the same UCB unit For the enhancement of cell engraftment in patients receiving hematopoietic stem cell transplantation (HSCT) 04/11/2018 Designated
661 Allogeneic, ex vivo expanded, umbilical cord blood-derived, hematopoietic CD34+ progenitor cells and Allogeneic, non-expanded, umbilical cord blood-derived, hematopoietic mature myeloid and lymphoid cells (Non-cultured fraction) Enhancement of cell engraftment and immune reconstitution in patients receiving hematopoietic stem cell transplant 05/23/2018 Designated
662 allogenic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor Treatment of macular telangiectasia type 2 (MacTel) 07/24/2012 Designated
663 allogeniec Human Pancreatic Islets of Langerhans Treatment of brittle type 1 diabetes 05/01/2019 Designated
664 allopregnanolone Treatment of status epilepticus 04/20/2014 Designated
665 allopregnanolone Treatment of Neimann-Pick disease, type C 07/12/2013 Designated/Withdrawn
666 Allopurinol riboside 1. Treatment of Chagas' disease 2. Treatment of cutaneous and visceral leishmaniasis 12/04/1985 Designated/Withdrawn
667 Allopurinol sodium Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. 10/16/1992 Designated/Approved
668 Allopurinol sodium Ex-vivo preservation of cadaveric kidneys for transplantation 11/09/1987 Designated/Withdrawn
669 allosteric activator of the red blood cell-specific form of pyruvate kinase Treatment of pyruvate kinase deficiency 03/24/2015 Designated
670 alpelisib Treatment of PIK3CA-related overgrowth spectrum 11/18/2019 Designated
671 alpha melanotropin Treatment of chronic beryllium disease 09/02/2010 Designated
672 alpha tocopherol and ascorbic acid Treatment of Fragile X syndrome 03/28/2019 Designated
673 alpha-1 proteinase inhibitor (human) Treatment of graft versus host disease 10/23/2014 Designated
674 alpha-1 proteinase inhibitor (human) Treatment of patients with recent onset (<15 years)with Type 1A diabetes mellitus with residual beta-cell function 07/28/2011 Designated
675 alpha-1 proteinase inhibitor (human) Prevention of graft versus host disease 07/31/2017 Designated
676 Alpha-1-acid glycoprotein Treatment of tricyclic antidepressant poisoning 03/17/2004 Designated/Withdrawn
677 Alpha-1-acid glycoprotein Treatment of cocaine overdose 03/05/2004 Designated/Withdrawn
678 Alpha-1-antitrypsin (recombinant DNA Origin) As supplementation therapy for alpha-1-antitrypsin deficiency in the ZZ phenotype population. 01/01/1984 Designated/Withdrawn
679 Alpha-galactosidase A Treatment of alpha-galactosidase A deficiency (Fabry's disease). 06/17/1991 Designated
680 Alpha-galactosidase A Long-term enzyme replacement therapy for the treatment of Fabry disease 06/22/1998 Designated
681 Alpha-galactosidase A Treatment of Fabry's disease. 07/20/1990 Designated
682 Alpha-melanocyte stimulating hormone Prevention and treatment of intrinsic acute renal failure due to ischemia. 08/19/1997 Designated
683 Alpha-tocopherol quinone Treatment of inherited mitochondrial respiratory chain diseases 03/28/2006 Designated
684 alpha-tocotrienol quinone Treatment of inherited mitochondrial respiratory chain diseases 10/21/2010 Designated
685 alpha1 proteinase inhibitor (human) Treatment of emphysema secondary to congenital alpha1-antitrypsin deficiency. 01/29/2010 Designated
686 Alpha1-antitrypsin(human) Treatment of bronchiectasis 04/03/2008 Designated
687 alpha1-proteinase inhibitor (human) Treatment of cystic fibrosis 04/06/2012 Designated
688 alpha1-proteinase inhibitor (human) Treatment of cystic fibrosis 02/20/2009 Designated
689 Alpha1-proteinase inhibitor (human) For slowing the progression of emphysema in alpha1-antitrypsin deficient patients. 11/24/1999 Designated/Withdrawn
690 Alpha1-proteinase inhibitor (human) For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state. 12/07/1984 Designated/Approved
691 alpha1-proteinase inhibitor (human) Treatment of Type 1 diabetes mellitus patients with residual beta-cell function. 03/03/2015 Designated
692 Alpha1-Proteinase Inhibitor (Human) Inhalation therapy for the treatment of congential deficiency of alpha1-proteinase inhibitor. 12/22/2004 Designated
693 Alpha1-Proteinase Inhibitor (Human) Treatment of cystic fibrosis 09/01/2004 Designated
694 Alprostadil Treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, grafts or angioplasty, are not indicated. 10/20/1993 Designated/Withdrawn
695 alteplase Treatment of plastic bronchitis 10/20/2014 Designated
696 alteplase Treatment of intraventricular hemorrhage associated with intracerebral hemorrhage 01/27/2003 Designated
697 altiratinib Treatment of glioblastoma multiforme. 08/19/2014 Designated
698 Altretamine Treatment of advanced adenocarcinoma of the ovary. 02/09/1984 Designated/Approved
699 Alvocidib Teatment of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic leukemia arising from CLL. 04/13/2007 Designated
700 alvocidib Treatment of acute myeloid leukemia 04/21/2014 Designated
701 Amantadine HCl Treatment of levodopa-induced dyskinesia 07/20/2015 Designated/Withdrawn
702 Amantadine hydrochloride Treatment of levodopa-induced dyskinesia 04/09/2015 Designated/Approved
703 amatuximab Treatment of mesothelioma 09/28/2012 Designated
704 ambrisentan Treatment of pulmonary arterial hypertension 07/16/2004 Designated/Approved
705 ambrisentan Treatment of idiopathic pulmonary fibrosis 12/23/2009 Designated/Withdrawn
706 ambrisentan/tadalafil fixed combination Treatment of pulmonary arterial hypertension 08/22/2016 Designated/Withdrawn
707 ambroxol Treatment of Gaucher disease 06/29/2011 Designated
708 amifampridine Treatment of Lambert-Eaton myasthenic syndrome. 12/18/1990 Designated/Approved
709 amifampridine phosphate Treatment of myasthenia gravis 08/31/2016 Designated
710 amifampridine phosphate Treatment of Lambert-Eaton Myasthenic Syndrome 11/12/2009 Designated/Approved
711 amifampridine phosphate Treatment of congenital myasthenic syndromes 03/03/2015 Designated
712 Amifostine Treatment of myelodysplastic syndromes. 10/04/1999 Designated
713 Amifostine For use as a chemoprotective agent for cisplatin in the treatment of metastatic melanoma. 05/30/1990 Designated
714 Amifostine Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer. 05/12/1998 Designated/Approved
715 Amifostine For use as a chemoprotective agent for cyclophosphamide in the treatment of advanced ovarian carcinoma. 05/30/1990 Designated
716 Amifostine For use as a chemoprotective agent for cisplatin in the treatment of advanced ovarian carcinoma. 05/30/1990 Designated/Approved
717 Amifostine For the reduction of the incidence and severity of toxicities associated with cisplatin administration. 11/24/1998 Designated
718 amikacin sulfate Management of cystic fibrosis patients with Pseudomonas aeruginosa lung infections 01/05/2015 Designated
719 Amiloride HCl solution for inhalation Treatment of cystic fibrosis. 07/18/1990 Designated/Withdrawn
720 Aminocaproic acid For the topical treatment of traumatic hyphema of the eye. 01/06/1995 Designated
721 aminolevulinic acid hydrochloride Treatment of esophageal dysplasia 03/20/2007 Designated
722 Aminosalicylate sodium Treatment of Crohn's disease. 04/06/1993 Designated/Withdrawn
723 Aminosalicylic acid Treatment of tuberculosis infections 02/19/1992 Designated/Approved
724 Aminosidine Treatment of Mycobacterium avium complex. 11/15/1993 Designated
725 Aminosidine Treatment of tuberculosis. 05/14/1993 Designated
726 Aminosidine Treatment of visceral leishmaniasis (kala-azar). 09/09/1994 Designated
727 aminosidine Treatment of visceral leishmaniasis 03/29/2005 Designated
728 Amiodarone Treatment of incessant ventricular tachycardia. 08/17/1993 Designated
729 Amiodarone HCl For the acute treatment and prophylaxis of life-threatening ventricular tachycardia or ventricular fibrillation. 03/16/1994 Designated/Approved
730 Amitriptyline Treatment of Erythromelalgia 05/27/2020 Designated
731 amitriptyline and ketamine Treatment of postherpetic neuralgia 01/19/2010 Designated
732 ammonium 21-tungsto-9-antimoniate Treatment of acquired immunodeficiency syndrome. 07/17/1985 Designated/Withdrawn
733 ammonium tetrathiomolybdate Treatment of idiopathic pulmonary fibrosis 05/05/2008 Designated
734 Ammonium tetrathiomolybdate Treatment of Wilson's disease. 01/31/1994 Designated
735 Ammonium trichloro dioxoethylene-O,O') tellurium (IV) Treatment of acquired immunodeficiency syndrome. 11/09/1987 Designated/Withdrawn
736 Amonafide L-malate Treatment of acute myeloid leukemia 12/20/2006 Designated/Withdrawn
737 amphotericin B Treatment of visceral leishmaniasis. 09/15/2010 Designated
738 Amphotericin B inhalation powder Prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies 12/15/2005 Designated/Withdrawn
739 Amphotericin B lipid complex Treatment of invasive coccidioidomycosis. 05/06/1996 Designated/Withdrawn
740 Amphotericin B lipid complex Treatment of invasive candidiasis. 06/27/1996 Designated/Withdrawn
741 Amphotericin B lipid complex Treatment of invasive sporotrichosis. 09/23/1996 Designated/Withdrawn
742 Amphotericin B lipid complex Treatment of invasive zygomycosis. 05/06/1996 Designated/Withdrawn
743 Amphotericin B lipid complex Treatment of invasive protothecosis. 08/21/1996 Designated/Withdrawn
744 Amphotericin B lipid complex Treatment of invasive fungal infections. 12/05/1991 Designated/Approved
745 amrubicin Treatment of small cell lung cancer 03/10/2008 Designated/Withdrawn
746 Amsacrine Treatment of acute adult leukemia. 12/07/1984 Designated/Withdrawn
747 Amyl nitrite, sodium nitrite, sodium thiosulfate Treatment of cyanide poisoning 12/18/2006 Designated
748 amylopectin Treatment of glycogen storage disease types Ia and Ib 03/24/2015 Designated
749 an adeno-associated viral vector containing a codon-optimised human factor IX gene (AAV5-hFIXco) Treatment of hemophilia B 12/22/2011 Designated
750 An Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua (AAV8.ss-3xCRM8-TTRFIX_R338Lopt) Treatment of Hemophilia B 01/13/2020 Designated
751 An asymmetric immunoglobulin G1 (IgG1)-based, B-cell maturation antigen (BCMA) x CD3 T-cell bispecific monoclonal antibody Treatment of multiple myeloma 08/28/2019 Designated
752 ANA-conjugated dactunomycin nanoemulsion Treatment of Ewing sarcoma 07/07/2015 Designated
753 Anagrelide Treatment of thrombocytosis in chronic myelogenous leukemia. 07/14/1986 Designated
754 Anagrelide Treatment of essential thrombocythemia. 01/27/1988 Designated/Approved
755 Anagrelide Treatment of polycythemia vera. 06/11/1985 Designated
756 anakinra Treatment of cryopyrin-associated periodic syndromes 08/19/2010 Designated/Approved
757 Ananain, comosain For the enzymatic debridement of severe burns. 01/21/1992 Designated
758 Anaritide acetate Improvement of early renal allograft function following renal transplantation. 04/10/1992 Designated/Withdrawn
759 Anaritide acetate Treatment of patients with acute renal failure. 08/27/1992 Designated/Withdrawn
760 Anatibant Treatment of patients having experienced a severe traumatic brain injury (Glasgow Coma Scale 3 to 8) in order to decrease early mortality and improve long-term functional and neurological outcome 04/15/2005 Designated
761 Ancestim For use in combination with filgrastim to decrease the number of phereses required to collect peripheral blood progenitor cells capable of providing rapid multi-lineage hematopoietic reconstitution following myelosuppressive or myeloablative therapy. 07/05/1995 Designated/Withdrawn
762 Ancrod To establish and maintain anticoagulation in heparin-intolerant patients undergoing cardiopulmonary bypass. 10/20/1989 Designated
763 anfibatide Treatment of thrombotic thrombocytopenic purpura. 03/10/2016 Designated
764 Angiotensin (1-7) Treatment of limb-girdle muscular dystrophy 11/26/2013 Designated
765 Angiotensin (1-7) Treatment of LAMA2-related muscular dystrophy 02/08/2016 Designated
766 angiotensin (1-7) Treatment of patients requiring stem cell transplantation to accelerate the mobilization of hematopoietic stem cells (CD34+) from the bone marrow to the peripheral blood when combined with a granulocyte colony-stimulating factor 08/30/2013 Designated
767 Angiotensin (1-7) Treatment of recessive dystrophic epidermolysis bullosa (RDEB). 09/01/2016 Designated
768 angiotensin (1-7)A(1-7) Treatment of Duchenne muscular dystrophy 07/25/2013 Designated
769 angiotensin 1-7 To accelerate engraftment of hematopoietic cells (treatment of neutropenia, thrombocytopenia, lymphoma, and aneima)in hematopoietic stem cell transplants. 06/17/2010 Designated
770 Angiotensin 1-7 Treatment of myelodysplastic syndrome 08/03/2001 Designated
771 Angiotensin 1-7 Treatment of neutropenia associated with autologous bone marrow transplantation. 02/16/2000 Designated
772 angiotensin 1-7 Treatment of sarcoma. 01/29/2010 Designated
773 Angiotensin II type 2 receptor agonist Treatment of pediatric cardiomyopathy 07/03/2017 Designated
774 Angiotensin-(1-7) Treatment of pulmonary arterial hypertension. 09/13/2011 Designated
775 anhydrous enol-oxaloacetate Treatment of hepatocellular carcinoma 03/07/2018 Designated
776 anisina Treatment of neuroblastoma. 07/14/2015 Designated
777 Anlotinib Treatment of soft tissue sarcoma 06/19/2017 Designated
778 anlotinib hydrochloride Treatment of ovarian cancer 12/31/2015 Designated
779 ansuvimab Treatment of Ebola Virus Disease 05/08/2019 Designated
780 ansuvimab Post-exposure prophylaxis against Ebola virus infection 03/30/2020 Designated
781 antagonist of chemokine Ligand-2 Treatment of pancreatic cancer 07/03/2017 Designated/Withdrawn
782 antagonist of the complement 5a receptor Treatment of atypical hemolytic uremic syndrome 11/17/2014 Designated
783 antagonist of the complement 5a receptor Treatment of anti-neutrophil cytoplasmic autoantibodies associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis), microscopic polyangiitis, and Churg-Strauss syndrome. 06/02/2014 Designated
784 antagonist of the endosomal Toll-like receptors (TLRs) 7, 8, and 9 Treatment of Waldenstrom's macroglobulinemia 12/23/2014 Designated
785 anthrax immune globulin Treatment of inhalation anthrax disease 09/03/2009 Designated/Withdrawn
786 anthrax immune globulin (human) Treatment of inhalational anthrax 07/29/2008 Designated/Approved
787 Anthrax Vaccine Adsorbed For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure 04/11/2014 Designated/Approved
788 anti human Nogo-A human monoclonal antibody Treatment of acute spinal cord injury 10/20/2008 Designated/Withdrawn
789 Anti pan T lymphocyte monoclonal antibody 1. For ex-vivo treatment to eliminate mature T cells from potential bone marrow grafts 2. For in-vivo treatment of bone marrow recipients to prevent graft rejection and graft versus host disease. 01/29/1986 Designated/Withdrawn
790 anti-angiogenic peptide Treatment of ovarian cancer 06/21/2017 Designated
791 anti-beta1 integrin monoclonal antibody Treatment of glioblastoma 08/07/2014 Designated
792 anti-Beta1 integrin monoclonal antibody Treatment of ovarian cancer 01/13/2015 Designated
793 anti-CD23 IgG1, kappa monoclonal antibody Treatment of chronic lymphocytic leukemia 02/12/2003 Designated/Withdrawn
794 anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein and anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft versus host disease 09/13/2013 Designated
795 anti-CD30 Fc engineered humanized monoclonal antibody Treatment of Hodgkin lymphoma 12/02/2008 Designated
796 Anti-CD45 monoclonal antibodies Prevention of acute graft rejection of human organ transplants. 09/10/1990 Designated/Withdrawn
797 anti-CD47 monoclonal antibody Treatment of multiple myeloma 07/30/2018 Designated
798 Anti-CEA Sheep-human chimeric monoclonal antibody labeled w/iodine-131 (KAb201) Treatment of pancreatic cancer 05/21/2003 Designated/Withdrawn
799 Anti-cytomegalovirus monoclonal antibodies 1. Treatment of human cytomegalovirus infection in patients diagnosed with AIDS 2. Prevention of human cytomegalovirus infection in patients diagnosed with AIDS 05/03/1990 Designated/Withdrawn
800 Anti-cytomegalovirus monoclonal antibodies 1. Treatment of human cytomegalovirus infection in bone marrow and organ transplant patients 2. Prevention of human cytomegalovirus infection in bone marrow and organ transplant patients 05/02/1990 Designated/Withdrawn
801 anti-EGFR VHH Fragment Fused to Cytosine Deaminase Treatment of pancreatic cancer 02/26/2020 Designated
802 anti-EGFRvIII x anti-CD3 bispecific T cell engager antibody construct Treatment of glioblastoma 04/02/2018 Designated
803 Anti-EphA1 monoclonal antibody conjugated to mcMMAF Treatment of ovarian cancer 07/27/2009 Designated/Withdrawn
804 Anti-eTau Humanized IgG4 Monoclonal Antibody Treatment of Progressive Supranuclear Palsy 05/13/2015 Designated
805 anti-HER2 bispecific antibody Treatment of ovarian cancer 05/18/2016 Designated
806 Anti-HER2 bispecific antibody Treatment of gastric cancer, including cancer of the gastroesophageal junction 02/06/2017 Designated
807 anti-HER2 bispecific antibody drug conjugate Treatment of ovarian cancer 07/06/2016 Designated/Withdrawn
808 anti-human epidermal growth factor receptor 2 (HER2) antibody drug conjugate Treatment of gastric cancer including cancer of gastroesophageal junction 02/01/2018 Designated
809 anti-inhibitor coagulant complex Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors 04/12/2013 Designated/Approved
810 anti-interferon-gamma Fab from goats For the treatment of immunologic corneal allograft rejection 11/18/2003 Designated
811 anti-interleukin 21 (NNC0114-0006) in combination with liraglutide Treatment of Type I Diabetes Mellitus with residual beta cell function. 01/12/2017 Designated
812 anti-Lewis Y humanized monoclonal antibody Treament of ovarian cancer 03/09/2012 Designated
813 anti-nogo-A monoclonal antibody Treatment of amyotrophic lateral sclerosis 07/07/2009 Designated/Withdrawn
814 anti-sense oligonucleotide consisting of 2’0-Me RNA with a phosphorothioate backbone Treatment of cystic fibrosis 09/23/2013 Designated
815 anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody Treatment of pancreatic cancer 08/29/2016 Designated
816 Anti-STAT3 B VHH13 single domain antibody Treatment of osteosarcoma 09/27/2017 Designated
817 Anti-T cell receptor murine monoclonal antibody Prophylaxis of acute rejection of solid organ transplantation 04/03/2009 Designated
818 anti-T-lymphocyte immune globulin, rabbit Prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation 09/12/2008 Designated
819 anti-T-lymphocyte immune globulin, rabbit Prevention of graft versus host disease (GVHD) 03/26/2010 Designated
820 Anti-tap-72 immunotoxin Treatment of metastatic colorectal adenocarcinoma. 03/06/1987 Designated/Withdrawn
821 anti-TCR murine monoclonal antibody (MAb, type IgM) Treatment of patients 16 years of age and younger with immune-mediated T1DM and preserved pancreatic beta cell function 06/07/2010 Designated
822 anti-TCR murine monoclonal antibody (MAB, type IgM) Treatment of pediatric multiple sclerosis in patients less than or equal to 16 years of age 01/12/2011 Designated
823 Anti-tenascin 81C6 monoclonal antibody labeled w/ I 131 Treatment of primary malignant brain tumors 10/04/2005 Designated
824 anti-thymocyte Globulin (rabbit) Treatment of myelodysplastic syndrome 09/06/2000 Designated/Withdrawn
825 anti-thymocyte globulin rabbit Prophylaxis of acute organ rejection in patients receiving renal transplants 05/25/2010 Designated
826 Anti-thymocyte serum Treatment of allograft rejection, including solid organ (kidney, liver, heart, lung, and pancreas) and bone marrow transplantation. 06/02/1993 Designated
827 Anti-transforming growth factor beta (TGF-ß) trap fusion protein Treatment of systemic sclerosis. 03/25/2019 Designated
828 anti-tumor necrosis factor (TNF) polyclonal antibody (bovine) Treatment of pediatric ulcerative colitis (0 through 16 years of age) 11/17/2014 Designated
829 Anti-vascular endothelial growth factor, anti-hepatocyte growth factor Designed Ankyrin Repeat Protein Treatment of multiple myeloma 12/23/2019 Designated
830 Anti-von Willebrand Aptamer Treatment of thrombotic thrombocytopenic purpura 04/09/2008 Designated/Withdrawn
831 antiangiogenic components extracted from marine cartilage Treatment of renal cell carcinoma 10/16/2002 Designated
832 Antibody drug conjugate consisting of a humanized IgG1 anti-NaPi2b monoclonal antibody and monomethyl auristatin E Treatment of ovarian cancer 07/29/2014 Designated/Withdrawn
833 antibody drug conjugate consisting of fully human anti-guanylyl cyclase C monoclonal antibody linked to the cytotoxic drug monomethyl auristatin E Treatment of gastric cancer 07/21/2014 Designated/Withdrawn
834 antibody drug conjugate of metal-binding motif-introduced trastuzumab antibody variant and monomethyl auristatin E Treatment of Gastric Cancer 07/30/2018 Designated
835 antibody drug conjugate targeting dipeptidase 3 (DPEP3) Treatment of DPEP3-positive ovarian, fallopian tube, and primary peritoneal cancers 01/08/2018 Designated/Withdrawn
836 antibody-drug conjugate comprised of a human aglycosylated anti-CD74 IgG1 antibody (SP7219) and two non-cleavable maytansinoid linker warheads Treatment of multiple myeloma 10/10/2018 Designated
837 Antiepilepsirine Treatment of drug resistant generalized tonic-clonic epilepsy in children and adults. 03/23/1989 Designated
838 Antihemophilic factor (human) Treatment of von Willebrand's disease 01/05/1996 Designated/Approved
839 Antihemophilic factor (recombinant) Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A. 09/25/1989 Designated/Approved
840 Antihemophilic factor (recombinant) For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). 02/08/1996 Designated/Approved
841 Antihemophilic factor (recombinant) formulated with sucrose reconstituted with liposome diluent Treatment of hemophilia A 04/29/2009 Designated/Withdrawn
842 antihemophilic factor (recombinant), Fc fusion protein Treatment of hemophilia A 11/23/2010 Designated/Approved
843 antihemophilic factor (recombinant), porcine sequence Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII 03/16/2004 Designated/Approved
844 Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized Treatment of patients with von Willebrand's disease 10/16/1992 Designated/Approved
845 Antimelanoma Antibody XMMME-001-DTPA 111 Indium Diagnostic use in imaging systemic and nodal melanoma metastasis. 11/14/1984 Designated/Withdrawn
846 Antimelanoma Antibody XMMME-001-RTA Treatment of stage III melanoma not amenable to surgical resection. 11/14/1984 Designated/Withdrawn
847 antimesothelin-ADC (antibody drug conjugate) Treatment of mesothelioma 07/05/2012 Designated/Withdrawn
848 antineoplaston A10, antineoplaston AS2-1 Treatment of gliomas 11/21/2008 Designated
849 antinuclear antibody conjugated liposomal doxorubicin Treatment of Ewing's sarcoma. 02/03/2015 Designated
850 Antipyrine Test For use as an index of hepatic drug-metabolizing capacity. 02/21/1985 Designated/Withdrawn
851 Antisense 20-mer oligonucleotide complementary to R2 component of ribonucleotide reductase mRNA Treatment of acute myeloid leukemia 04/15/2005 Designated
852 antisense 20-mer phosphorothioate oligonucleotide complementary to the coding region of R2 component of the human ribonucleotide reductase mRNA Treatment for renal cell carcinoma 03/12/2003 Designated
853 antisense oligonucleotide complementary to the exonic splicer enhancer sequence at intron 26 of the centrosomal protein 290 pre-mRNA Treatment of Leber's congenital amaurosis. 05/25/2016 Designated
854 Antisense oligonucleotide directed against connexin43 Treatment of persistent corneal epithelial defects 04/27/2009 Designated
855 antisense oligonucleotide inhibitor of the expression of superoxide dismutase 1 gene Treatment of amyotrophic lateral sclerosis 09/19/2016 Designated
856 antisense oligonucleotide specific to the antisense transcript of UBE3A Treatment of Angelman Syndrome 03/15/2018 Designated/Withdrawn
857 antisense oligonucleotide targeting exon 13 of the USH2A gene Treatment of retinitis pigmentosa 07/27/2017 Designated
858 antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of dystrophic epidermolysis bullosa 09/13/2017 Designated
859 [[antisense oligonucleotide targeting the c.7595-2144A>G mutation in intron 40 of the USH2A gene]] Treatment of retinitis pigmentosa 06/28/2017 Designated
860 antisense oligonucleotide targeting the P23H mutation of the RHO gene Treatment of retinal dystrophy dut to the P23H gene mutation (retinitis pigmentosa) 11/18/2019 Designated
861 antisense oligonucleotide targeting the U isoform of SNP rs362307 Treatment of Huntington's disease (prodromal stage Huntington's disease and diagnosed Huntington's disease) 06/16/2016 Designated
862 Antithrombin III (human) For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. 02/08/1985 Designated/Approved
863 Antithrombin III (human) For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli. 11/26/1984 Designated/Approved
864 Antithrombin III (human) concentrate IV For prophylaxis and treatment of thromboembolic episodes in patients with genetic AT-III deficiency. 07/02/1985 Designated/Withdrawn
865 Antithrombin III human Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition. 01/02/1986 Designated
866 Antivenin crotaline (pit-viper) equine immune F(ab)2) Treatment of envenomation by Crotaline snakes 01/29/2004 Designated/Approved
867 Antivenin, crotalidae polyvalent immune Fab (ovine) Treatment of envenomations inflicted by North American crotalid snakes. 01/12/1994 Designated/Approved
868 Antivenom (crotalidae) purified (avian) Treatment of envenomation by poisonous snakes belonging to the Crotalidae family. 02/12/1991 Designated
869 antroquinonol Treatment of hepatocellular carcinoma 07/23/2015 Designated
870 antroquinonol Treatment of acute myeloid leukemia 04/30/2015 Designated
871 antroquinonol Treatment of pancreatic cancer 01/21/2015 Designated
872 apatinib mesylate Treatment of gastric cancer 06/15/2017 Designated
873 aphidicolin Treatment of Ebola virus infection 04/20/2016 Designated
874 apilimod dimesylate Treatment of follicular lymphoma 07/01/2019 Designated
875 apolipoprotein E mimetic peptide Treatment of homozygous familial hypercholesterolemia 12/03/2012 Designated
876 apolipoprotein E mimetic peptide (AEM-28(R)-14) Treatment of homozygous familial hypercholesterolemia (HoFH) 08/07/2017 Designated
877 Apomorphine For use as rescue treatment for early morning motor dysfunction in late-stage Parkinson's disease. 10/20/1997 Designated/Withdrawn
878 Apomorphine Treatment of the on-off fluctuations associated with late-stage Parkinson's disease. 07/17/1995 Designated
879 Apomorphine HCl Treatment of the on-off fluctuations associated with late-stage Parkinson's disease. 04/22/1993 Designated/Approved
880 Apomorphine hydrochloride For the treatment of patients in a vegetative state or minimally conscious state for up to 12 months following a severe traumatic brain injury (traumatic or spontaneous) 05/23/2006 Designated
881 apomorphine palmitate Treatment of Acute Myeloid Leukemia 06/04/2018 Designated
882 apraglutide Treatment of short bowel syndrome (SBS) 12/20/2018 Designated
883 apremilast Treatment of Behcet's disease 01/17/2013 Designated/Approved
884 apremilast Treatment of pediatric patients with ulcerative colitis 01/17/2018 Designated
885 Aprotinin For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary coronary artery bypass graft surgery where the risk of bleeding is especially high (impaired hemostasis) or where transfusion is unavailable or unacceptable. 11/17/1993 Designated/Approved
886 AQ-13 (4-aminoquinoline analog) Treatment of malaria 09/12/2008 Designated
887 Arcitumomab Diagnosis and localization of primary, residual, recurrent and metastatic medullary thyroid carcinoma. 05/10/1996 Designated/Withdrawn
888 Arenegyr Treatment of malignant pleural mesothelioma 08/22/2008 Designated
889 Arginine butyrate Treatment of sickle cell disease and beta thalassemia. 05/25/1994 Designated/Withdrawn
890 Arginine butyrate Treatment of beta-hemoglobinopathies and beta-thalassemia. 04/07/1992 Designated
891 arimoclomol Treatment of amyotrophic lateral sclerosis 03/29/2005 Designated
892 arimoclomol Treatment of inclusion body myositis 11/02/2017 Designated
893 arimoclomol citrate Treatment of Neimann-Pick disease, type C 01/13/2015 Designated
894 Aripiprazole Treatment of N-glycanase 1 (NGLY1) deficiency 07/22/2019 Designated
895 aripiprazole Treatment of Tourette's syndrome 01/25/2006 Designated/Approved
896 arsenic Treatment of acute myelocytic leukemia subtypes M0, M1, M2, M4, M5, M6 and M7 11/02/2001 Designated
897 arsenic trioxide Treatment of myelodysplastic syndrome. 07/17/2000 Designated
898 Arsenic trioxide Treatment of malignant glioma 03/04/2005 Designated
899 Arsenic trioxide Treatment of multiple myeloma. 04/28/2000 Designated
900 Arsenic trioxide Treatment of chronic lymphocytic leukemia 05/13/2003 Designated
901 Arsenic trioxide Treatment of acute promyelocytic leukemia. 03/03/1998 Designated/Approved
902 Arsenic trioxide Treatment of acute promyelocytic leukemia. 03/03/1998 Designated/Approved
903 arsenic trioxide Treatment of liver cancer 06/13/2003 Designated
904 arsenic trioxide Treatment of chronic myeloid leukemia 10/18/2001 Designated
905 arsenic trioxide Treatment of Graft-versus-host disease 07/30/2018 Designated
906 arsenic trioxide capsule (oral) Treatment of acute promyelocytic leukemia. 11/02/2015 Designated
907 artemether/lumefantrine For the treatment of infections due to Plasmodium falciparum or mixed infections including P. falciparum. 08/31/2007 Designated/Approved
908 artemisone Treatment of malaria 07/19/2017 Designated
909 Artesunate Treatment of malaria 09/05/2017 Designated
910 Artesunate Treatment of malaria. 07/19/1999 Designated
911 artesunate Immediate treatment of malaria 03/28/2006 Designated/Approved
912 artesunate Treatment of malaria 07/22/2019 Designated
913 arylsulfatase A (rhASA) Treatment of metachromatic leukodystrophy 02/27/2008 Designated
914 asciminib Treatment of chronic myelogenous leukemia 02/27/2017 Designated
915 ascorbic acid Treatment of lung dysfunction following lung transplant 12/12/2016 Designated
916 ascorbic acid Treatment of cystic fibrosis 07/30/2018 Designated
917 ascorbic acid Treatment of Charcot-Marie-Tooth disease type 1A. 05/11/2009 Designated
918 ascorbic acid Treatment of scurvy 08/31/2007 Designated/Approved
919 Asfotase alfa Treatment of hypophosphatasia 09/12/2008 Designated/Approved
920 astuprotimut-R Treatment of MAGE-A3 positive stages IIb to IV malignant melanoma 05/29/2009 Designated/Withdrawn
921 astuprotimut-R Treatment of MAGE-A3 positive non-small cell lung cancer 05/29/2009 Designated
922 ataluren For use in the treatment of cystic fibrosis resulting fron a nonsense (premature stopcodon) mutation in the cystic bibrosis transmembrane conductance regulatory gene 09/01/2004 Designated/Withdrawn
923 ataluren Treatment of Muscular Dystrophy resulting from premature stop mutations in the dystrohin gene 01/10/2005 Designated
924 ataluren Treatment of aniridia 09/01/2015 Designated
925 ataluren Treatment of mucopolysaccharidosis type I 12/10/2014 Designated/Withdrawn
926 ataluren Treatment of spinal muscular atrophy 03/10/2008 Designated
927 atezolizumab Treatment of small cell lung cancer (SCLC) 10/13/2016 Designated/Approved
928 Atezolizumab Treatment of patients with stage IIb, IIc, III, and IV melanoma 02/13/2017 Designated
929 atezolizumab Treatment of Stage llb, llc, lll and IV melanoma 02/13/2017 Designated
930 atezolizumab + bevacizumab Treatment of hepatocellular carcinoma (HCC) 01/08/2018 Designated/Approved
931 atezolizumab + bevacizumab Treatment of hepatocellular carcinoma (HCC) 01/08/2018 Designated/Approved
932 atoltivimab, odesivimab and maftivimab Post-exposure prophylaxis against Ebola virus infection 12/23/2019 Designated
933 Atomoxetine hydrochloride Treatment of Tourette's Syndrome 08/26/2003 Designated/Withdrawn
934 Atovaquone Treatment of AIDS associated Pneumocystis Carinii Pneumonia. 09/10/1990 Designated/Approved
935 Atovaquone Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3. 08/14/1991 Designated/Approved
936 Atovaquone Primary prophylaxis of HIV-infected persons at high risk for developing Toxoplasma gondii encephalitis. 03/16/1993 Designated/Withdrawn
937 Atovaquone Treatment and suppression of Toxoplasma gondii encephalitis. 03/16/1993 Designated/Withdrawn
938 Atrasentan Treatment of pediatric nephrotic syndrome 09/29/2016 Designated/Withdrawn
939 Attenuated autologous cancer cells and granulocyte macrophage colony stimulating factor in combination with activated autologous blood derived T-cells Treatment of primary central nervous system malignancies 04/27/2007 Designated
940 auranofin Treatment of amebiasis 04/30/2010 Designated
941 Autologous Activated T Lymphocytes (ATL) Treatment of hepatocellular carcinoma (HCC) 03/28/2018 Designated
942 autologous adipose derived mesenchymal stromal cells Treatment of amyotrophic lateral sclerosis 10/22/2014 Designated
943 autologous adipose tissue derived mesenchymal stem cells Treatment of Buerger's disease (thromboangiitis obliterans). 05/04/2016 Designated
944 autologous adult bone marrow-derived and unexpanded CD133+ hematopoietic stem cells (CD133+ BMDSCs) mobilized from peripheral blood (PB) Treatment of women with infertility and a thin endometrium seeking pregnancy 02/01/2019 Designated
945 Autologous adult live cultured osteoblasts Treatment of osteonecrosis 12/20/2018 Designated
946 autologous antigen presenting cells pulsed with autologous tumor Ig idiotype Treatment of multiple myeloma 04/18/2002 Designated/Withdrawn
947 Autologous auricular cartilage construct for subcutaneous implantation Treatment of microtia (including anotia) 11/06/2019 Designated
948 autologous bone marrow CD34+ cells transduced ex vivo with a self activating HIV-1 -based lentiviral vector, EFS-ADA Treatment of adenosine deaminase deficient severe combined immunodeficiency 10/21/2014 Designated
949 Autologous CD3+ T cells genetically modified using a non-viral system to express a CD33 CAR, membrane bound Interleukin-15, and a truncated form of human HER1t (kill switch) on the cell surface. Treatment of acute myeloid leukemia 12/31/2019 Designated
950 Autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor) Treatment of acute lymphoblastic leukemia (ALL) 11/13/2014 Designated/Withdrawn
951 autologous CD34+ bone marrow derived stem cells transduced with a self-inactivating gammaretroviral vector encoding the human IL2RG (yc) Treatment of severe combined immune deficiency-X1 01/15/2015 Designated
952 autologous CD34+ cell enriched hematopoietic stem cells genetically modified ex vivo with a lentiviral vector to contain codon-optimized complementary deoxyribonucleic acid that encodes human beta-glucocerebrosidase Treatment of Gaucher disease 09/25/2019 Designated
953 autologous CD34+ cell- enriched population transduced with lentiviral vector encoding the codon-optimized human alpha-galactosidase A complementary deoxyribonucleic acid sequence. Treatment of Fabry Disease 12/17/2018 Designated
954 autologous CD34+ Cells Enriched with Blood Derived Mitochondria Treatment of Pearson Syndrome 02/26/2019 Designated
955 Autologous CD34+ cells transduced with gamma globin lentiviral vector Treatment of sickle cell disease 01/14/2020 Designated
956 autologous CD34+ cells transduced with lentiviral vector which encodes for the aryl Sulfatase A complimentary deoxyribonucleic acid sequence Treatment of the Metachromatic Leukodystrophy (including pre-symptomatic metachromatic leukodystrophy) 03/08/2018 Designated
957 Autologous CD34+ cells transfected with lentiviral vector containing the human WAS cDNA (Telethon 003) Treatment of Wiskott Aldrich syndrome 04/30/2010 Designated
958 Autologous CD34+ enriched cell population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human gp91phox gene Treatment of X-linked chronic granulomatous disease (X-CGD) 01/16/2020 Designated
959 autologous CD34+ enriched cells transduced with a lentiviral vector containing RNA resulting in codon-optimized cDNA encoding for functional human cystinosin Treatment of cystinosis 03/04/2020 Designated
960 Autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease messenger RNAs SB-mRENH1 and SB-mRENH2 Treatment of Sickle Cell Disease 06/11/2019 Designated
961 autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease messenger RNAs SB-mRENH1 and SB-mRENH2 Treatment of ß-thalassemia 06/04/2019 Designated
962 autologous CD34+ hematopoietic stem cells tranduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA Treatment of andrenoleukodystrophy 04/19/2012 Designated
963 Autologous CD34+ hematopoietic stem cells transduced with an hCD11b lentiviral vector encoding for the human N-sulfoglucosamine sulfohydrolase (SGSH) gene Treatment of mucopolysaccharidosis IIIA 05/03/2017 Designated
964 autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene For the treatment of Sickle Cell Disease 02/26/2014 Designated
965 autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene Treatment of B-thalassemia major and intermedia 03/18/2013 Designated
966 Autologous CD4+/CD8+ T cells expressing a BCMA-specific chimeric antigen receptor (CAR) Treatment of Multiple Myeloma (MM) 09/28/2017 Designated
967 autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor (CAR) and a truncated epidermal growth factor receptor. Treatment of chronic lymphocytic leukemia 10/04/2016 Designated
968 autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor and a truncated epidermal growth factor receptor Treatment of acute lymphoblastic leukemia 09/07/2016 Designated
969 autologous CD4+/CD8+ T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 Treatment of acute lymphoblastic leukemia (inclusive of B-cell acute lymphoblastic leukemia) 11/06/2014 Designated/Withdrawn
970 Autologous CD4+/CD8+ T cells transduced with lentiviral vector directed against the NY-ESO-1 protein Treatment of soft tissue sarcoma. 03/28/2016 Designated
971 autologous CD4+CD25hiFoxP3+regulatory T cells Prevention of graft rejection following solid organ transplantation 11/19/2013 Designated
972 autologous chimeric antigen receptor (CAR) T cells targeting intercellular adhesion molecule-1 (ICAM-1) Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and recurrent or metastatic follicular or papillary thyroid cancer 04/09/2019 Designated
973 Autologous cultured endothelial cells on a donor human corneal disk Treatment of Fuch's dystrophy, pseudophakic bullous keratopathy, and bullous keratopathy 06/01/2007 Designated
974 autologous Cytokine-Induced Killer Cells (Cytokine-induced Killer Cells plus Cytotoxic T Lymphocytes) Treatment of Pancreatic Cancer. 09/10/2018 Designated
975 Autologous Cytokine-Induced Killer Cells (Cytokine-Induced Killer Cells Plus Cytotoxic T Lymphocytes) Treatment of glioblastoma 08/01/2018 Designated
976 Autologous Cytokine-Induced Killer Cells (Cytokine-Induced Killer Cells plus Cytotoxic T Lymphocytes) Treatment of Hepatocellular Carcinoma 06/21/2018 Designated
977 Autologous dendritic cell/tumor antigens Treatment of glioblastoma multiforme (GBM) 09/27/2016 Designated
978 Autologous dendritic cells ex vivo incubated with zebularine and factor VIII Treatment to reduce factor VIII neutralizing antibodies (inhibitors) 09/24/2018 Designated
979 autologous dendritic cells pulsed with allogeneic tumor cell lysate Treatment of malignant mesothelioma 05/06/2014 Designated
980 Autologous dendritic cells pulsed with autologous antigens from primay malignant brain tumor cells Treatment of primary brain malignant cancer 11/29/2002 Designated
981 autologous dendritic cells pulsed with hepatitis B virus antigens Treatment of hepatocellular carcinoma 10/25/2018 Designated
982 Autologous dendritic cells pulsed with recombinant human fusion protein (mucin1- glutathione S transferase) coupled to oxidized polymannose Treatment of ovarian cancer. 09/13/2010 Designated
983 Autologous Desmoglein 3 (DSG3) Chimeric Autoantibody Receptor-directed (CAAR) T cells Treatment of pemphigus vulgaris 01/28/2020 Designated
984 Autologous DNP-conjugated tumor vaccine For adjuvant therapy in melanoma patients with surgically resectable lymph node metastasis (Stage III and limited Stage IV disease). 02/23/1999 Designated
985 Autologous Engineered Skin Substitute Treatment of hospitalized patients with deep partial and full thickness burns requiring grafting. 06/01/2012 Designated
986 autologous engineered T-cell product that targets B-cell maturation antigen (BCMA) Treatment of multiple myeloma 09/10/2018 Designated/Withdrawn
987 autologous enriched T cells transduced with a lentiviral vector to express an anti-CD19 Chimeric Antigen Receptor Treatment of acute lymphoblastic leukemia 11/04/2019 Designated
988 Autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors (CARs) targeting cluster of differentiation (CD) 19 and CD 22. Treatment of Acute Lymphoblastic Leukemia 04/17/2019 Designated
989 autologous Epstein-Barr specific T-cells Treatment of post-transplant lymphoproliferative disorder 05/31/2017 Designated
990 autologous Epstein-Barr virus specific T-cells Treatment of Epstein-Barr virus positive non-Hodgkin lymphomas. 03/09/2015 Designated
991 autologous ex vivo expanded CD4+-enriched leukocytes treated with the de-methylating agent 5-aza-2â⿬⿢-deoxycytidine Treatment of glioblastoma multiforme 09/13/2013 Designated
992 autologous ex vivo expanded polyclonal CD4+CD25+CD1271o/-FOXP3+ Regulatory T cells Treatment of type 1 diabetes mellitus with residual beta cell function 05/10/2016 Designated
993 autologous genetically engineered T cells that express a single-domain antibody that recognizes human mesothelin fused to the cluster of differentiation 3e subunit of the T cell receptor Treatment of mesothelioma 02/01/2019 Designated
994 Autologous genetically modified CD34+ hematopoietic cells transduced with a lentiviral vector (LV-EFS-TCIRG1-WPRE) that encodes for the human TCIRG1 transgene Treatment of infantile malignant osteopetrosis 02/28/2019 Designated
995 autologous genetically modified human dermal fibroblasts Treatment of dystrophic epidermolysis bullosa. 06/10/2014 Designated
996 autologous glioma tumor cells treated with 18-mer oligodeoxynucleotide sequence complementary to insulin-like growth factor type 1 receptor (IGF-1R) codons 2-7 in the IG-1R gene Treatment of malignant glioma 10/11/2017 Designated
997 autologous human adipose perivascular stromal cells genetically modified to secrete soluble Tumor Necrosis Factor-related Apoptosis-inducing Ligand (sTRAIL) Treatment of Pancreatic Cancer 05/22/2018 Designated
998 autologous human peripheral blood mononuclear cells incubated ex vivo with protein TBX-4000 (Tat-MYC) Treatment of malignant melanoma Stages IIb to IV 10/16/2017 Designated
999 Autologous incubated macrophage Therapy to improve the motor and sensory neurological outcome in acute cases of spinal cord injury 09/03/2004 Designated
1000 autologous lymphocytes depleted ex vivo of immunoreactive T cells using 4,5 Treatment of chronic graft versus host disease 04/03/2008 Designated
1001 Autologous lymphoma-derived immunoglobulin idiotype antigen vaccine conjugated to keyhole limpet hemocyanin Treatment of Waldenstrom's macroglobulinemia 10/18/2011 Designated
1002 Autologous modified RNA transfected myeloid cells that express a fusion protein composed of humanized scFv that recognizes human CD5, a CD8 alpha transmembrane domain, and Fc gamma and PI3K intracellular signaling domains (CD5-ATAK-Fcy-PI3K Myeloid Cells) Treatment of T-cell Lymphoma 03/16/2020 Designated
1003 autologous mononuclear cells derived from umbilical cord blood Treatment of severe pediatric congenital heart disease 07/13/2017 Designated
1004 autologous neo-uninary conduit Treatment of bladder dysfunction requiring incontinent urinary diversion. 06/07/2011 Designated
1005 Autologous olfactory neural progenitors Treatment of spinal cord injury patients with ASIA Impairment grades A, B, or C 02/01/2008 Designated
1006 autologous olfactory neural progenitors Treatment of amyotrophic lateral sclerosis 12/31/2008 Designated
1007 Autologous or allogeneic limbal epithelial stem cells expanded ex vivo on human amniotic membrane Treatment of ocular surface diseases that are characterized by total limbal stem cell deficiency 07/14/2005 Designated
1008 autologous osteogenic cells cultured from adipose tissue derived stem cells embedded in extracellular matrix with demineralized bone matrix. Treatment of congenital pseudarthrosis of the tibia 06/30/2016 Designated/Withdrawn
1009 Autologous stromal vascular cell fraction from adipose tissue (central facitily processed) Treatment of impaired hand function due to systemic sclerosis 11/09/2016 Designated
1010 autologous T cells expressing a transmembrane chimeric antigen receptor (CAR) to target anti-delta-like ligand 3 Treatment of small cell lung cancer 12/18/2019 Designated
1011 autologous T cells genetically modified to express CD123 specific hinge-optimized CD28-costimulatory chimeric receptor and a truncated human epidermal growth factor receptor Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm 12/17/2018 Designated
1012 autologous T cells transduced with retroviral vector encoding a hepatitis B virus antigen-specific T cell receptor Treatment of hepatocellular carcinoma 07/03/2017 Designated
1013 Autologous T cells transfected with mRNA encoding hepatitis B virus antigen-specific T cell receptor Treatment of hepatocellular carcinoma 07/03/2017 Designated
1014 Autologous T cells transfected with PiggyBac transposon plasmid vector expressing B-cell maturation antigen (CAR-T cells) Treatment of Multiple Myeloma 05/08/2019 Designated
1015 [[autologous T lymphocyte enriched population cultured in the rpesence of phosphatidylinositol 3-kinase inhibitor (bb007) that contains cells transduced with an anti-human B cell maturation antigen (BCMA02) chimeric antigen receptor (CAR) lentiviral vector encoding a CAR that targets human BCMA]] Treatment of multiple myeloma 10/05/2017 Designated
1016 Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signaling domains Treatment of Multiple Myeloma 02/26/2020 Designated
1017 autologous T-cells genetically engineered via lentiviral vector technology to express a synthetic receptor directed against B-cell maturation antigen (BCMA) protein target Treatment of multiple myeloma (MM) 02/01/2019 Designated
1018 autologous T-cells genetically modified to express a CD123-specific, hinge-optimized, CD28-costimulatory chimeric receptor and a truncated human epidermal growth factor receptor Treatment of acute myeloid leukemia 07/22/2019 Designated
1019 Autologous T-cells genetically modified using a lentiviral vector encoding for CD19 CD3e TRuC Treatment of acute lymphoblastic leukemia 05/11/2020 Designated
1020 autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor Treatment of chronic lymphocytic leukemia. 04/20/2016 Designated
1021 autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor Treatment of mantle cell lymphoma. 04/28/2016 Designated
1022 Autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor Treatment of acute lymphoblastic leukemia. (ALL). 04/20/2016 Designated
1023 autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen Treatment of multiple myeloma 05/11/2016 Designated
1024 autologous tumor cells fused with polyethylene glycol to human allogeneic FO-1, DNA plasmid transfected tumor cell line Treatment of glioblastoma 05/06/2015 Designated
1025 autologous tumor infiltrating lymphocytes (TIL) Treatment of cervical cancer with a tumor size greater than 2 cm. in diameter 04/30/2018 Designated
1026 autologous tumor-derived gp96 heat shock protein-peptide complex Treatment of metastatic melanoma 07/11/2002 Designated
1027 autologous tumor-derived gp96 heat shock protein-peptide complex Treatment of renal cell carcinoma 05/10/2002 Designated
1028 autologous umbilical cord blood Treatment of pediatric (0-16 yrs old inclusive) cerebral palsy due to acquired brain injury 07/24/2012 Designated
1029 autologus CD34+ cells transfected with retroviral vector containing adenosine deaminase gene Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency. 08/26/2009 Designated
1030 Autolymphocyte therapy Treatment of renal cell carcinoma. 07/12/1994 Designated
1031 Autotaxin inhibitor Treatment of Idiopathic Pulmonary Fibrosis 01/14/2019 Designated
1032 Avacopan Treatment of C3 glomerulopathy 03/20/2017 Designated
1033 avalglucosidase alfa Treatment of Pompe Disease 11/19/2013 Designated
1034 avapritinib Treatment of gastrointestinal stromal tumors 01/06/2016 Designated/Approved
1035 avatrombopag maleate Treatment of idiopathic thrombocytopenic purpura 09/01/2011 Designated/Approved
1036 avatrombopag maleate Treatment of chemotherapy-induced thrombocytopenia 12/19/2019 Designated
1037 avelumab Treatment of gastric cancer (GC) including cancer of the gastroesophageal junction (GEJ) 10/11/2017 Designated
1038 avelumab (Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) Treatment of merkel cell carcinoma. 09/21/2015 Designated/Approved
1039 avicin d Treatment of multiple myeloma 03/24/2015 Designated
1040 aviptadil Treatment of pulmonary arterial hypertension 02/22/2005 Designated
1041 axicabtagene ciloleucel Treatment of nodal marginal zone lymphoma 03/24/2020 Designated
1042 axicabtagene ciloleucel Treatment of diffuse large B-cell lymphoma 03/27/2014 Designated/Approved
1043 axicabtagene ciloleucel Treatment of extranodal marginal zone lymphoma 03/23/2020 Designated
1044 axicabtagene ciloleucel Treatment of follicular lymphoma. 04/25/2016 Designated/Approved
1045 axicabtagene ciloleucel Treatment of primary mediastinal B-cell lymphoma. 04/20/2016 Designated/Approved
1046 axitinib Treatment of pancreatic cancer 05/31/2007 Designated/Withdrawn
1047 azacitidine Treatament of myelodysplastic syndromes 12/03/2001 Designated/Approved
1048 Azacitidine Treatment of acute myeloid leukemia 06/18/2008 Designated
1049 Azathioprine Treatment of oral manifestations of graft-versus-host disease. 09/14/1999 Designated
1050 aztreonam Improvement of respiratory symptoms in patients with bronchiectasis and gram-negative bacteria in the airways. 05/15/2009 Designated/Withdrawn
1051 aztreonam Inhalation therapy for control of gram-negative bacteria in the respiratory tract of patients with cystic fibrosis 03/12/2002 Designated/Approved
1052 Azurin-p28 Treatment of glioma 12/02/2015 Designated
1053 B Lymphocyte Stimulator Treatment of common variable immunodeficiency (CVID) 02/21/2001 Designated/Withdrawn
1054 Bacillus Calmette-Guerin vaccine Treatment of stage IIb through IV metastatic melanoma 08/09/2006 Designated
1055 Bacillus subtilis oxalate decarboxylase Treatment of pediatric hyperoxaluria 02/29/2016 Designated
1056 Bacillus subtilis oxalate decarboxylase Treatment of primary hyperoxaluria 06/12/2017 Designated
1057 Bacillus thuringiensis crystal protein (Cry5B) Treatment of gastroinstestinal infections caused by ascaris lumbricoides (roundworm), trichuris trichiura (whipworm), ancylostoma duodenale, necator americanus, and ancylostoma ceylanicum (hookworms) 03/07/2018 Designated
1058 Bacitracin Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile. 03/13/1984 Designated
1059 baclofen Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy). 11/10/1987 Designated/Approved
1060 baclofen Treatment of dystonia 12/02/2003 Designated
1061 baclofen Treatment of complex regional pain syndrome 10/28/2015 Designated
1062 baclofen Treatment of intractable spasticity due to multiple sclerosis or spinal cord injury. 12/16/1991 Designated/Approved
1063 Baclofen Treatment of spasticity associated with cerebral palsy. 09/26/1994 Designated
1064 bacterium Bacteroides thetaiotaomicron Treatment of active Crohn's disease in the pediatric population 09/26/2013 Designated
1065 Balipodect Treatment of CDKL5 deficiency disorder 06/19/2019 Designated
1066 Balipodect Treatment of Fragile X Syndrome 06/13/2019 Designated
1067 Balsalazide disodium Treatment of pediatric patients with ulcerative colitis 08/12/2005 Designated/Approved
1068 Bardoxolone Treatment of pancreatic cancer 08/06/2008 Designated
1069 bardoxolone Treatment of pulmonary arterial hypertension 03/30/2015 Designated
1070 bardoxolone methyl Treatment of autosomal dominant polycystic kidney disease 06/03/2019 Designated
1071 bardoxolone methyl Treatment of Alport Syndrome 07/03/2017 Designated
1072 baricitinib Treatment of pediatric systemic lupus erythematosus 11/02/2017 Designated
1073 Basiliximab Prophylaxis of solid organ rejection. 12/12/1997 Designated/Approved
1074 basimglurant Treatment of Fragile X Syndrome 03/09/2012 Designated
1075 BCL-005 (fused (hybrid) melanoma-dendritic cells) Treatment of stage IIb to IV melanoma in HLA-A2 positive patients 10/21/2010 Designated/Withdrawn
1076 beclomethasone Treatment of pediatriac patients with ulcerative colitis 03/04/2009 Designated
1077 beclomethasone 17,21-dipropionate Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster 11/19/2012 Designated
1078 beclomethasone 17,21-dipropionate Treatment of gastrointestinal symptoms with chronic graft versed host disease in patients undergoing allogenic hematopoietic cell transplantation 07/24/2009 Designated
1079 beclomethasone 17,21-dipropionate Prevention of gastrointestinal graft-versus-host disease 08/28/2001 Designated
1080 beclomethasone 17,21-diproprionate Treatment of pediatric patients with Crohn disease. 12/18/2007 Designated
1081 beclomethasone dipropionate For oral administration in the treatment of intestinal graft-versus-host disease. 03/27/1998 Designated
1082 bedaquiline Treatment of active tuberculosis 01/10/2005 Designated/Approved
1083 Bedaquiline Treatment of Nontuberculosis Mycobacteria infection 07/27/2017 Designated
1084 bedaquiline Treatment of active tuberculosis 01/10/2005 Designated/Approved
1085 bedaquiline Treatment of active tuberculosis 01/10/2005 Designated/Approved
1086 belatacept Prophylaxis of organ rejection in renal allograft recipients 02/20/2008 Designated/Approved
1087 Belinostat Treatment of peripheral T-cell lymphoma (PTCL). 09/03/2009 Designated/Approved
1088 beloranib Treatment of Prader-Willi syndrome 01/15/2013 Designated/Withdrawn
1089 bempegaldesleukin Treatment of Stage IIb to Stage IV melanoma 04/17/2020 Designated
1090 bendamustine Treatment of multiple myeloma 06/22/2017 Designated
1091 bendamustine for 50 ml admixture Treatment of chronic lymphocytic leukemia 07/02/2014 Designated/Approved
1092 bendamustine for 50ml admixture Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma) 07/02/2014 Designated/Approved
1093 bendamustine hydrochloride Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma) 11/26/2013 Designated/Approved
1094 Bendamustine hydrochloride Treatment of chronic lymphocytic leukemia 08/17/2007 Designated/Approved
1095 bendamustine hydrochloride with betadex sulfobutyl ether sodium Treatment of chronic lymphocytic leukemia 09/10/2013 Designated
1096 Bendamustine oral doseage formulation Treatment of chronic lymphocytic leukemia 11/05/2015 Designated
1097 benralizumab Treatment of eosinophilic esophagitis 08/26/2019 Designated
1098 benralizumab Treatment of hypereosinophilic syndrome 02/01/2019 Designated
1099 benralizumab Treatment of eosinophilic granulomatosis with polyangiitis 11/21/2018 Designated
1100 Benzeneacetamide, 2-2-2-2-methoxy-4-(1-methyl-4-piperidinyl)phenylamino-5-(trifluoromethyl)-4-pyrimidinylethyl- Treatment of idiopathic pulmonary fibrosis 05/18/2020 Designated
1101 benzeneacetamide, 2-2-2-2-methoxy-4-(1-methyl-4-piperidinyl)phenylamino-5-(trifluoromethyl)-4-pyrimidinylethyl- Treatment of pancreatic cancer 03/23/2020 Designated
1102 benznidazole Treatment of Chagas disease 04/14/2014 Designated/Approved
1103 benznidazole Treatment of Chagas disease 07/05/2017 Designated
1104 benzoate Treatment of pediatric schizophrenia 07/06/2012 Designated
1105 Benzoate and phenylacetate For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency. 01/21/1986 Designated/Approved
1106 benzoate/phenylacetate Treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. 11/22/1993 Designated/Approved
1107 Benzophenone-3, octylmethoxycinnamate, avobenzone, titanium dioxide, zinc oxide For the prevention of visible light induced skin photosensitivity as a result of porfimer sodium photodynamic therapy 08/13/2001 Designated
1108 Benzydamine hydrochloride Prophylactic treatment of oral mucositis resulting from radiation therapy for head and neck cancer. 05/18/1998 Designated
1109 Benzylpenicillin, benzylpenicilloic, benzylpenilloic acid Assessing the risk of administrating penicillin when it is the preferred drug of choice in adult patients who have previously received penicillin and have a history of clinical sensitivity. 09/28/1987 Designated
1110 Beractant Treatment of neonatal respiratory distress syndrome 02/05/1986 Designated/Approved
1111 Beractant Treatment of neonatal respiratory distress syndrome 02/05/1986 Designated/Approved
1112 Beractant Treatment of full-term newborn infants with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis. 12/20/1993 Designated
1113 Beraprost Treatment of pulmonary arterial hypertension associated with any New York Heart Association classification (Class I, II, III, or IV). 04/29/1999 Designated/Withdrawn
1114 beraprost sodium 314d Treatment of pulmonary arterial hypertension 12/22/2011 Designated/Withdrawn
1115 bercolagene telserpavec Treatment of dystrophic epidermolysis bullosa 11/02/2017 Designated
1116 berotralstat Treatment of C1-inhibitor-dependent angioedema (including prevention and treatment of attacks) 11/01/2017 Designated
1117 bertilimumab Treatment of bullous pemphigoid 08/17/2018 Designated
1118 Berubicin Treatment of malignant glioma 06/09/2020 Designated
1119 Beta alethine Treatment of metastatic melanoma. 03/24/1997 Designated
1120 Beta alethine Treatment of multiple myeloma. 03/24/1997 Designated
1121 Betahistine dihydrochloride Treatment of obesity associated with Prader Willi syndrome 11/08/2007 Designated
1122 Betaine Treatment of homocystinuria. 05/16/1994 Designated/Approved
1123 betamethasone Treatment of Ataxia Telangiectasia. 10/07/2015 Designated
1124 Bethanidine sulfate Treatment of primary ventricular fibrillation. 09/20/1988 Designated/Withdrawn
1125 Bethanidine sulfate Prevention of recurrence of primary ventricular fibrillation. 11/24/1989 Designated/Withdrawn
1126 Betulinic acid Topical treatment of metastatic melanoma 08/09/2007 Designated
1127 bevacizumab Treatment of primary peritoneal carcinoma. 11/02/2010 Designated/Approved
1128 bevacizumab Treatment of pancreatic cancer 10/20/2004 Designated/Withdrawn
1129 bevacizumab Treatment of hereditary hemorrhagic telangiectasia 10/21/2010 Designated
1130 bevacizumab Treatment of fallopian tube carcinoma 11/23/2010 Designated/Approved
1131 bevacizumab Treatment of malignant glioma 05/26/2006 Designated/Approved
1132 bevacizumab Treatment of melanoma stages IIb through IV as part of a combination chemotherapy regimen 10/13/2009 Designated/Withdrawn
1133 bevacizumab Treatment of fallopian tube carcinoma 11/23/2010 Designated/Approved
1134 bevacizumab Therapeutic treatment of patients with ovarian cancer 02/09/2006 Designated/Approved
1135 bevacizumab Treatment of renal cell carcinoma 11/06/2003 Designated/Approved
1136 bevacizumab Treatment of mesothelioma 01/27/2016 Designated/Withdrawn
1137 bevacizumab Treatment of Coat's disease 03/10/2016 Designated
1138 bevacizumab Treatment of primary peritoneal carcinoma. 11/02/2010 Designated/Approved
1139 bevacizumab Treatment of primary peritoneal carcinoma. 11/02/2010 Designated/Approved
1140 bevacizumab In combination with a platinum and 5-FU or capecitabine for the treatment of stomach cancer. 11/20/2009 Designated/Withdrawn
1141 bevacizumab Therapeutic treatment of patients with ovarian cancer 02/09/2006 Designated/Approved
1142 bevacizumab Treatment of fallopian tube carcinoma 11/23/2010 Designated/Approved
1143 bevacizumab Therapeutic treatment of patients with ovarian cancer 02/09/2006 Designated/Approved
1144 Bexarotene Treatment of cutaneous T-cell lymphoma. 06/18/1999 Designated/Approved
1145 bezafibrate For therapeutic treatment of Barth syndrome 07/24/2013 Designated
1146 bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine Treatment of Ewing's sarcoma 10/22/2014 Designated
1147 bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine Treatment of ovarian cancer 04/18/2011 Designated
1148 bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine Treatment of stage IIB to IV melanoma 02/17/2012 Designated
1149 bicarbonate infusate Use in the management of patients undergoing continuous renal replacement therapy with hemofiltration 08/09/2005 Designated/Approved
1150 bictegravir/emtricitabine/tenofovir disoproxil fumarate Treatment of Human Immunodeficiency Virus type 1 infection in pediatric patients 05/17/2017 Designated/Approved
1151 bifidobacterium infantis 35624 Treatment of pediatric ulcerative colitis 03/24/2008 Designated
1152 bifidobacterium longum infantis 35624 Treatment of pediatric Crohn's disease 01/16/2003 Designated
1153 bilayer, engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts Treatment of partial deep dermal and full thickness burn wounds 09/06/2016 Designated
1154 bimagrumab Treatment of inclusion body myositis 06/18/2012 Designated/Withdrawn
1155 Bindarit Treatment of lupus nephritis. 02/03/1998 Designated
1156 binimetinib Treatment Stage IIB-IV melanoma. 11/19/2013 Designated
1157 binimetinib Treatment of ovarian cancer 07/31/2014 Designated
1158 Bio-engineered oral mucosal tissue For use as a graft for restoring a cornea-like epithelial phenotype to substitute for the normal corneal epithelium that is lost in patients due to total limbal stem cell deficiency 04/27/2006 Designated
1159 Bioartificial liver system utilizing xenogenic hepatocytes in a hollow fiber bioreactor cartridge (BAL) Treatment of patients with acute liver failure presenting with encephalopathy deteriorating beyond Parson's grade 2 02/11/2002 Designated
1160 Bis(4-fluorophenyl)phenylacetamide Treatment of sickle cell disease. 03/02/2000 Designated
1161 bis-choline tetrathiomolybdate Treatment of Amyotrophic Lateral Sclerosis (ALS) 06/05/2017 Designated
1162 bis-choline tetrathiomolybdate Treatment of primary biliary cholangitis 04/06/2020 Designated
1163 bisantrene HCl Treatment of acute myeloid leukemia 02/14/2014 Designated
1164 Bismuth-1,2-ethanedithiol; 1,2-Bis-((1,3-dithia-2-bismolan)-2-yl) thioethane Treatment (management) of pulmonary infections in patients with Cystic Fibrosis 08/21/2019 Designated
1165 bispecific antibody (monoclonal antibody) Treatment of HER2-expressing adenocarcinoma of the esophagus 08/08/2013 Designated
1166 bispecific antibody (monoclonal antibody) Treatment of HER2-expressing advanced adenocarcinoma of the stomach and gastroesophageal junction 08/08/2013 Designated
1167 Bispecific antibody 520c9x22 For in vivo serotherapy of patients with ovarian cancer. 10/05/1993 Designated/Withdrawn
1168 bispecific Antibody simultaneously targeting CD38 and CD3 Treatment of multiple myeloma 09/11/2019 Designated
1169 bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13) Treatment of idiopathic pulmonary fibrosis. 09/14/2011 Designated/Withdrawn
1170 bispecific T cell engager antibody construct with a half-life extension Fc moiety capable of binding to the neonatal Fc receptor Treatment of Acute Myeloid Leukemia 09/11/2019 Designated
1171 bispecific T-cell engager (BiTE) antibody targeting CD33 and CD3 Treatment of Acute Myeloid Leukemia 07/01/2019 Designated
1172 Bispecific T-cell engager (BiTE) containing two single-chain variable fragment (scFv) domains directed against the B cell maturation antigen (BCMA) surface receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T-cells Treatment of multiple myeloma 02/08/2019 Designated
1173 bispecific T-cell engager antibody consisting of 2 single chain variable fragment binding domains specific for antigen Delta-like protein 3 (DLL3) and for TCR-associated complex CD3 Treatment of small cell lung cancer (SCLC) 12/27/2018 Designated
1174 bispecific T-cell engager antibody with a single chain Fc moiety that binds to B cell maturation antigen surface receptor and CD3 Treatment of multiple myeloma 10/10/2018 Designated
1175 bitopertin Treatment of ß-thalassemia 08/16/2017 Designated/Withdrawn
1176 bivalent anti-human myostatin adnectin-IgG1 Treatment of duchenne muscular dystrophy 02/10/2015 Designated
1177 bivalirudin For use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome 11/02/2005 Designated
1178 Bleomycin Treatment of pancreatic cancer. 02/09/1999 Designated
1179 Bleomycin Treatment of pancreatic cancer. 12/20/2010 Designated
1180 Bleomycin sulfate Treatment of malignant pleural effusion. 09/17/1993 Designated/Approved
1181 blinatumomab Treatment of acute lymphocytic leukemia 05/16/2008 Designated/Approved
1182 Blinatumomab Treatment of chronic lymphocytic leukemia 05/16/2008 Designated
1183 blinatumomab Treatment of diffuse large B-cell lymphoma (DLBCL) 07/06/2017 Designated
1184 blinatumomab Treatment of indolent B-cell lymphoma, excluding CLL and NHL with CNS involvement 02/06/2006 Designated
1185 blinatumomab Treatment of acute lymphocytic leukemia 05/16/2008 Designated/Approved
1186 blinatumomab Treatment for hairy cell leukemia. 05/16/2008 Designated
1187 blinatumomab Treatment of prolymphocytic leukemia 05/16/2008 Designated
1188 blisibimod Treatment of patients with immunoglobulin A nephropathy 08/07/2017 Designated
1189 BN-Brachyury; a heterologous prime/boost therapeutic cancer vaccine composed of MVA-BN-Brachyury (prime) and FPV-Brachyury (boost) Treatment of chordoma 04/30/2018 Designated
1190 Bone marrow-derived mononuclear cells Treatment of thromboangiitis obliterans (Buerger's disease) 05/17/2010 Designated
1191 bortezomib Treatment of multiple myeloma 01/15/2003 Designated/Approved
1192 bortezomib Treatment of multiple myeloma 01/15/2003 Designated/Approved
1193 bortezomib Treatment of acute lymphoblastic leukemia 02/03/2015 Designated/Withdrawn
1194 bortezomib Treatment of mantle cell lymphoma. 05/30/2012 Designated/Approved
1195 bortezomib Treatment of follicular non-Hodgkin lymphoma 01/04/2011 Designated/Withdrawn
1196 bortezomib Treatment of multiple myeloma 01/15/2003 Designated/Approved
1197 bortezomib Treatment of neurofibromatosis type 2 (NF2) 07/05/2016 Designated
1198 bortezomib Treatment of mantle cell lymphoma. 05/30/2012 Designated/Approved
1199 bosentan Treatment of idiopathic pulmonary fibrosis 09/30/2008 Designated/Withdrawn
1200 bosentan Treatment of pulmonary arterial hypertension 10/06/2000 Designated/Approved
1201 bosentan Treatment of pulmonary arterial hypertension 10/06/2000 Designated/Approved
1202 bosentan Reduction of the number (treatment) of new digital ulcers in patients with systemic sclerosis 06/07/2010 Designated/Withdrawn
1203 bosutinib Treatment of chronic myelogenous leukemia 02/24/2009 Designated/Approved
1204 bosutinib Treatment of chronic myelogenous leukemia 02/24/2009 Designated/Approved
1205 Botulinum toxin type A Treatment of spasmodic torticollis (cervical dystonia). 08/12/1998 Designated
1206 Botulinum toxin type A Treatment of dynamic muscle contractures in pediatric cerebral palsy patients. 10/20/1999 Designated/Approved
1207 Botulinum toxin type A Treatment of essential blepharospasm. 03/23/1989 Designated
1208 Botulinum toxin type A Treatment of cervical dystonia. 08/20/1986 Designated/Approved
1209 Botulinum toxin type A Treatment of synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration. 09/15/1992 Designated
1210 Botulinum toxin type A Treatment of strabismus and blepharospasms 03/22/1984 Designated/Approved
1211 Botulinum toxin type A Treatment of strabismus and blepharospasms 03/22/1984 Designated/Approved
1212 botulinum toxin type A Treatment of dynamic muscle contracture in pediatric cerebral palsy patients 12/06/1991 Designated/Approved
1213 Botulinum toxin type A Treatment of essential blepharospasm. 12/05/1991 Designated
1214 Botulinum toxin type B Treatment of cervical dystonia. 01/16/1992 Designated/Approved
1215 Botulinum toxin type F Treatment of spasmodic torticollis (cervical dystonia). 10/24/1991 Designated
1216 botulism antitoxin heptavalent (A, B, C, D, E, F, G) (Equine) Treatment of botulism. 06/29/2011 Designated/Approved
1217 Botulism immune globulin Treatment of infant botulism. 01/31/1989 Designated/Approved
1218 Bovine colostrum Treatment of AIDS-related diarrhea. 11/19/1990 Designated
1219 Bovine immunoglobulin concentrate, Cryptosporidium parvum Treatment and symptomatic relief of Cryptosporidium parvum infection of the gastrointestinal tract in immunocompromised patients. 03/01/1994 Designated
1220 bovine lactoferrin Prevention of late-onset sepsis in very low birth weight infants 02/19/2015 Designated
1221 bovine lactoferrin Prevention of necrotizing enterocolitis in very low birth weight infants (birth weight less than or equal to 1500 grams) 02/23/2015 Designated
1222 Bovine whey protein concentrate Treatment of cryptosporidiosis caused by the presence of Cryptosporidium parvum in the gastrointestinal tract of patients who are immunodeficient/immunocompromised or immunocompetent. 09/30/1993 Designated
1223 branaplam Treatment of spinal muscular atrophy (SMA) 01/23/2018 Designated
1224 Branched chain amino acids Treatment of amyotrophic lateral sclerosis. 12/23/1988 Designated
1225 brentuximab vedotin Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranodal NK/T-cell lymphoma. 10/23/2008 Designated/Approved
1226 brentuximab vedotin Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranodal NK/T-cell lymphoma. 10/23/2008 Designated/Approved
1227 brentuximab vedotin Treatment of Hodgkin's lymphoma 01/30/2007 Designated/Approved
1228 brentuximab vedotin Treatment of patients with angioimmunoblastic T-cell lymphoma 09/13/2013 Designated/Withdrawn
1229 brentuximab vedotin Treatment of adult T-cell leukemia/lymphoma 05/23/2016 Designated/Withdrawn
1230 brentuximab vedotin Treatment of mycosis fungoides 11/19/2012 Designated/Approved
1231 brentuximab vedotin Treatment of enteropathy-associated T-cell lymphoma. 07/07/2016 Designated/Withdrawn
1232 brentuximab vedotin Treatment of patients with diffuse large B-cell lymphoma. 01/31/2014 Designated/Withdrawn
1233 brentuximab vedotin Treatment of patients with peripheral T-cell lymphoma, not otherwise specified 04/15/2013 Designated/Withdrawn
1234 brentuximab vedotin Treatment of extranodal NK/T-cell lymphoma (ENKTL) 11/13/2018 Designated/Withdrawn
1235 brentuximab vedotin Treatment of Hodgkin's lymphoma 01/30/2007 Designated/Approved
1236 Brentuximab vedotin Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders 09/07/2016 Designated/Approved
1237 brentuximab vedotin Treatment of Hodgkin's lymphoma 01/30/2007 Designated/Approved
1238 Brentuximab vedotin Treatment of cutaneous T-cell lymphoma 02/06/2017 Designated
1239 Brevenal Treatment of cystic fibrosis 04/02/2018 Designated
1240 brigatinib Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC). 04/28/2016 Designated/Approved
1241 brigatinib Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC). 04/28/2016 Designated/Approved
1242 brilliant blue G For use in ophthalmic surgery to aid in the removal of the inner limiting membrane of the eye. 12/16/2009 Designated
1243 Brilliant Blue G Ophthalmic Solution 0.025% For use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane 07/31/2012 Designated/Approved
1244 brimonidine Treatment of ocular graft versus host disease 08/03/2017 Designated
1245 Brimonidine Treatment of anterior ischemic optic neuropathy. 02/07/2000 Designated
1246 brincidofovir Treatment of Smallpox 06/05/2018 Designated
1247 brivanib alaninate Treatment of hepatocellular carcinoma 03/18/2011 Designated/Withdrawn
1248 brivaracetam Treatment of Childhood Absence Epilepsy 12/03/2019 Designated
1249 brivaracetam Treatment of symptomatic myoclonus 10/05/2005 Designated
1250 brivaracetam Treatment of Juvenile Absence Epilepsy 12/03/2019 Designated
1251 Brivudin Adjunct treatment of pancreatic cancer 11/15/2007 Designated/Withdrawn
1252 bromelain + acetylcysteine Treatment of pseudomyxoma peritonei with Bromelain and Acetylcysteine 12/27/2018 Designated
1253 Bromhexine Treatment of mild to moderate keratoconjunctivitis sicca in patients with Sjogren's syndrome. 05/15/1989 Designated/Withdrawn
1254 bromodomain and Extra-Terminal (BET) Inhibitor Treatment of acute myeloid leukemia 04/05/2017 Designated
1255 Broxuridine Radiation sensitizer in the treatment of primary brain tumors. 09/18/1995 Designated
1256 Bruton's tyrosine kinase inhibitor Treatment of chronic lymphocytic leukemia 02/10/2014 Designated/Withdrawn
1257 Bruton’s agammaglobulinemia tyrosine kinase (BTK) inhibitor Treatment of immune thrombocytopenic purpura (ITP) 10/15/2018 Designated
1258 bryostatin 1 Treatment of Fragile X Syndrome. 03/31/2015 Designated
1259 bryostatin-1 For use in combination with paclitaxel in the treatment of esophageal cancer 12/03/2001 Designated
1260 bucillamine Treatment of cystinuria 10/22/2015 Designated
1261 budesonide Treatment of Autoimmune Hepatitis 02/01/2019 Designated
1262 budesonide To slow the progression of immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease. 05/17/2010 Designated
1263 budesonide Treatment of primary biliary cholangitis 02/11/2019 Designated
1264 budesonide Treatment of patients with eosinophilic esophagitis 12/20/2006 Designated
1265 budesonide Treat of ulcerative colitis in pediatric patients aged 0 through 16 years. 05/06/2013 Designated
1266 budesonide Treatment of eosinophilic esophagitis 05/08/2018 Designated
1267 Buffered intrathecal electrolyte/dextrose injection For use as a diluent in the intrathecal administration of methotrexate and cytarabine for the prevention or treatment meningeal leukemia and lymphocytic lymphoma 08/24/1994 Designated/Approved
1268 Buffered Ursodeoxycholic Acid Treatment of pruritus in patients with Alagille Syndrome 09/03/2004 Designated
1269 bulevertide Treatment of hepatitis D virus infection. 03/31/2015 Designated
1270 bupivacaine Relief of persistent pain associated with postherpetic neuralgia 06/18/2008 Designated
1271 bupivacaine hydrochloride treatment of pain associated with postherpetic neuralgia. 05/31/2016 Designated
1272 Buprenorphine hydrochloride Treatment of opiate addiction in opiate users. 06/15/1994 Designated/Withdrawn
1273 Buprenorphine hydrochloride Treatment of opiate addiction in opiate users. 06/15/1994 Designated/Withdrawn
1274 buprenorphine in combination with naloxone Treatment of opiate addiction in opiate users 10/27/1994 Designated/Approved
1275 burosumab-twza Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets) 12/14/2009 Designated/Approved
1276 burosumab-twza Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets) 12/14/2009 Designated/Approved
1277 burosumab-twza Treatment of tumor-induced osteomalacia (TIO) syndrome 06/15/2017 Designated/Approved
1278 busulfan Preparative therapy for pediatric patients undergoing bone marrow transplantation 11/25/2002 Designated
1279 Busulfan Treatment of primary brain malignancies. 07/07/1997 Designated
1280 Busulfan For use as preparative therapy for malignancies treated with bone marrow transplantation. 04/21/1994 Designated
1281 Busulfan Intrathecal therapy for neoplastic meningitis 03/05/2001 Designated/Withdrawn
1282 Busulfan As preparative therapy in the treatment of malignancies with bone marrow transplantation. 07/28/1994 Designated/Approved
1283 Buthionine sulfoxamine Use as a modulator of chemotherapy for the treatment of pediatric patients with primary malignant brain tumors 10/05/2005 Designated
1284 Buthionine sulfoxamine For use in children as a modulator of chemotherapy for the treatment of pediatric patients with neuroblastoma 10/05/2005 Designated
1285 butylidenephthalide Treatment of Malignant Glioma 08/05/2015 Designated
1286 Butyrylcholinesterase For the reduction and clearance of toxic blood levels of cocaine encountered during a drug overdose. 03/25/1992 Designated
1287 Butyrylcholinesterase Treatment of post-surgical apnea. 09/30/1992 Designated
1288 c-myb antisense oligodeoxynucleotide Treatment of chronic myelogenous leukemia 02/22/2005 Designated/Withdrawn
1289 C-type natriuretic peptide conjugated to a multi-arm polyethylene glycol carrier molecule through a cleavable linker Treatment of Achondroplasia 02/27/2019 Designated
1290 C1 esterase inhibitor (human) Treatment of angioedema 07/16/2004 Designated/Approved
1291 C1 esterase inhibitor (human) Treatment and prevention of angioedema caused by C1-esterase inhibitor deficiency. 08/21/1996 Designated
1292 C1 esterase inhibitor (Human) Treatment of acute antibody mediated rejection following kidney transplantation 11/30/2016 Designated
1293 C1 esterase inhibitor (human) Treatment of angioedema 07/16/2004 Designated/Approved
1294 C1 esterase inhibitor, human Treatment of antibody mediated rejection (AMR) of solid organ transplants 04/05/2018 Designated
1295 C1-esterase inhibitor (recombinant) Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency. 02/23/1999 Designated/Approved
1296 C1-esterase-inhibitor, human, pasteurized Prevention and/or treatment of acute attacks of hereditary angioedema. 10/16/1992 Designated/Approved
1297 C1-esterase-inhibitor, human, pasteurized Prevention and/or treatment of acute attacks of hereditary angioedema. 10/16/1992 Designated/Approved
1298 C1-inhibitor Prevention of acute attacks of angioedema, including short-term prophylaxis for patients requiring dental or other surgical procedures. 08/30/1990 Designated/Withdrawn
1299 C1-inhibitor Treatment of acute attacks of angioedema. 08/30/1990 Designated/Withdrawn
1300 C20-D3-retinyl acetate Treatment of Stargardt's disease 09/16/2010 Designated
1301 C21H27O10P Treatment of gastric cancer. 03/30/2015 Designated
1302 C24H28N8O7S2 Treatment of diffuse large B-cell lymphoma (DLBCL). 04/02/2015 Designated
1303 C66H100N6O27 Treatment of of hepatocellular carcinoma 03/11/2013 Designated
1304 Cabiralizumab Treatment of pigmented villonodular synovitis and tenosynovial giant cell tumor 01/11/2016 Designated/Withdrawn
1305 cabozantinib Treatment of hepatocellular carcinoma. 03/02/2017 Designated/Approved
1306 cabozantinib Treatment of follicular, medullary and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer. 11/29/2010 Designated/Approved
1307 cadazolid Treatment of clostridium difficile infection in pediatric patients 08/08/2017 Designated
1308 Caffeine Treatment of apnea of prematurity. 09/20/1988 Designated/Approved
1309 caffeine and sodium benzoate Treatment of seizure prolongation in patients undergoing electroconvulsive therapy 08/22/2012 Designated
1310 Caflanone Treatment of Pancreatic Cancer 09/25/2019 Designated
1311 Calcitonin salmon nasal spray Treatment of symptomatic Paget's disease (osteitis deformans). 10/29/1990 Designated/Withdrawn
1312 Calcitonin-human for injection Treatment of symptomatic Paget's disease (osteitis deformans). 01/20/1987 Designated/Approved
1313 Calcium acetate Treatment of hyperphosphatemia in end stage renal failure. 12/22/1988 Designated/Approved
1314 Calcium acetate Treatment of hyperphosphatemia in end stage renal disease. 06/27/1989 Designated
1315 calcium benzoate and risperidone Treatment of pediatric patients with schizophrenia 12/20/2010 Designated
1316 Calcium carbonate Treatment of hyperphosphatemia in patients with end stage renal disease. 06/06/1990 Designated
1317 Calcium gluconate For use as a wash for hydrofluoric acid spills on human skin. 11/20/1997 Designated
1318 Calcium gluconate gel For use in the emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns. 05/21/1991 Designated
1319 Calcium gluconate gel 2.5% Emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns. 09/10/1990 Designated
1320 calfactant Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants. 06/07/1985 Designated/Approved
1321 calfactant Treatment of acute respiratory distress syndrome (ARDS) 09/05/2000 Designated
1322 calmangafodipir Treatment of acetaminophen overdose. 03/15/2019 Designated
1323 camostat Treatment of chronic pancreatitis 05/18/2011 Designated
1324 canakinumab Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis. 09/30/2008 Designated/Approved
1325 canakinumab Treatment of cryopyrin-associated periodic syndromes 12/18/2007 Designated/Approved
1326 canakinumab Treatment of familial mediterranean fever 12/05/2013 Designated/Approved
1327 canakinumab Treatment of adult-onset Still's Disease 07/31/2017 Designated
1328 canakinumab Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis. 09/30/2008 Designated/Approved
1329 canakinumab Treatment of TNF-receptor associated periodic syndrome (TRAPS) 09/04/2012 Designated/Approved
1330 canakinumab Treatment of hyperimmunoglobulinemia D and periodic fever syndrome 12/05/2013 Designated/Approved
1331 cannabidiol Treatment of infantile spasms 06/13/2016 Designated
1332 cannabidiol Treatment of glioma 09/24/2014 Designated
1333 cannabidiol Treatment of Lennox-Gastaut syndrome 02/27/2014 Designated/Approved
1334 cannabidiol Treatment of Dravet syndrome 11/14/2013 Designated/Approved
1335 cannabidiol Treatment of Dravet syndrome 07/01/2014 Designated/Withdrawn
1336 cannabidiol Treatment of infantile spasms 07/23/2015 Designated
1337 cannabidiol Treatment of pediatric schizophrenia (pediatrics is defined as 0 through 16 years of age) 11/17/2014 Designated
1338 cannabidiol Treatment of neonatal hypoxic ischemic encephalopathy 04/22/2015 Designated
1339 cannabidiol Prevention of ischemia/reperfusion Injury resulting from solid organ transplantation 11/05/2018 Designated
1340 cannabidiol Treatment of tuberous sclerosis complex. 04/19/2016 Designated
1341 cannabidiol Treatment of glioblastoma multiforme 08/20/2014 Designated
1342 cannabidiol Treatment of Graft versus Host Disease 11/29/2016 Designated
1343 cannabidiol Treatment of glioblastoma 04/28/2020 Designated
1344 cannabidiol Treatment of Lennox-Gastaut syndrome 06/23/2014 Designated/Withdrawn
1345 cannabidiol Treatment of childhood absence epilepsy 08/15/2019 Designated
1346 cannabidiol Treatment of Epidermolysis Bullosa 04/20/2020 Designated
1347 cannabidiol Prevention of Graft versus Host Disease (GVHD). 07/14/2015 Designated
1348 cannabidiol Treatment of Fragile X syndrome 02/23/2016 Designated
1349 cannabidiol Treatment of autoimmune hepatitis 06/25/2018 Designated
1350 cannabidiol Treatment of Dravet syndrome 12/21/2017 Designated
1351 cannabidiol (CBD) Treatment of Lennox-Gastaut syndrome 10/24/2017 Designated
1352 cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC) Treatment of glioblastoma multiforme 01/08/2018 Designated
1353 Cannabidiol and delta-9-tetrahydrocannabinol Treatment of amyotrophic lateral sclerosis 03/15/2018 Designated
1354 Cannabidivarin Treatment of Fragile X syndrome 06/06/2017 Designated
1355 cannabidivarin Treatment of Rett syndrome 11/30/2016 Designated
1356 cantharidin Treatment of perforating diseases, including Kyrle's disease, reactive perforating collangenosis, perforating folliculitis and elastosis perforans serpiginosa 07/24/2012 Designated
1357 cantrixil Treatment of ovarian cancer 04/20/2015 Designated
1358 Caplacizumab Treatment of thrombotic thrombocytopenic purpura 04/14/2009 Designated/Approved
1359 capmatinib Treatment of non-small cell lung cancer with MET genomic tumor aberrations 03/15/2019 Designated/Approved
1360 caprine hyperimmune serum against HIV lysate Treatment of systemic sclerosis 02/14/2014 Designated
1361 caprine hyperimmune serum against HIV lysate Treatment of amyotrophic lateral sclerosis 10/28/2009 Designated
1362 capsaicin Treatment of painful HIV-associated neuropathy 05/02/2003 Designated
1363 Capsaicin Treatment of postherpetic neuralgia. 08/03/2005 Designated
1364 capsaicin Treatment of erythromelalgia 10/23/2002 Designated
1365 capsaicin Treatment of intermetatarsal neuroma (Morton's Neuroma) that does not respond to conservative treatment and requires either neurectomy or neurolysis 09/29/2006 Designated
1366 capsaicin Management of neuropathic pain in patients with postherpetic neuralgia 05/22/2009 Designated/Approved
1367 carbamic acid, 4-3-4-1-(4-hydroxyphenyl)-1-methyl-ethylphenoxymethylphenylmethoxy-phenyliminomethyl-,ethyl ester Management of cystic fibrosis 01/15/2002 Designated/Withdrawn
1368 carbenoxolone Treatment of Huntington's Disease 07/02/2014 Designated
1369 carbetocin (nasal spray) Treatment of Prader Willi syndrome 04/11/2014 Designated
1370 carbon dioxide Treatment of trigeminal neuralgia 12/17/2015 Designated
1371 carbon monoxide Treatment of idiopathic pulmonary fibrosis (IPF). 08/16/2016 Designated
1372 carbon monoxide For use in the reduction of the incidence and severity of delayed graft function in patients undergoing solid organ transplanation. 06/24/2008 Designated/Withdrawn
1373 carbon monoxide Treatment of sickle cell disease 09/28/2012 Designated
1374 carbon monoxide Prevention of Primary Graft Dysfunction in transplant recipients receiving a lung or heart+ lung transplant. 04/14/2020 Designated
1375 carbon monoxide Prevention of delayed graft function in renal transplant recipients 08/01/2018 Designated
1376 Carbovir Treatment of persons with AIDS and in patients with symptomatic HIV infection and a CD4 count less than 200/mm3. 12/13/1989 Designated/Withdrawn
1377 carboxy pyrrolidine hexanoyl pyrrolidine carboxylate Treatment of AL amyloidosis 02/10/2015 Designated/Withdrawn
1378 carboxyamidotriazole orotate Treatment of malignant glioma 05/10/2018 Designated
1379 cardiotrophin-1 Treatment of acute liver failure 09/13/2011 Designated
1380 cardiotrophin-1 Prevention of ischemia-reperfusion injury in kidney transplant recipients 10/16/2014 Designated
1381 cardiotrophin-1 To protect the liver from ischemia-reperfusion injury inherent to the procedure of transplantation. 06/24/2008 Designated
1382 carfilzomib Treatment of multiple myeloma 01/18/2008 Designated/Approved
1383 carglumic acid Treatment of organic acidemias 06/17/2014 Designated
1384 carglumic acid Treatment of N-acetylglutamate synthetase deficiency. 01/20/1998 Designated/Approved
1385 carisbamate Management of patients with infantile spasms 03/16/2012 Designated
1386 carisbamate Treatment of Lennox-Gastaut syndrome 08/02/2017 Designated
1387 carlumab Treatment of pancreatic cancer 10/24/2006 Designated
1388 carlumab Treatment of idiopathic pulmonary fibrosis 11/08/2007 Designated/Withdrawn
1389 carmustine Conditioning treatment prior to hematopoietic progenitor cell transplantation 10/11/2017 Designated
1390 Carmustine Treatment of intracranial malignancies. 07/03/2000 Designated
1391 Cascara sagrada fluid extract Treatment of oral drug overdosage to speed lower bowel evacuation. 03/21/1989 Designated
1392 casimersen Treatment of Duchenne muscular dystrophy 06/04/2019 Designated
1393 CaspaCIDe System (combination product) consisting of allogeneic T Cell genetically modified to contain an inducible caspase 9 gene and Rimiducid Replacement T-cell therapy for the treatment of immunodeficiency and graft versus host disease after allogeneic hematopoietic stem cell transplant 02/18/2016 Designated
1394 Catumaxomab Treatment of ovarian cancer 06/09/2006 Designated
1395 catumaxomab Treatment of gastric cancer 07/01/2009 Designated
1396 CD3 and B-cell maturation antigen T-cell engaging bispecific antibody Treatment of Multiple Myeloma 10/17/2019 Designated
1397 CD34+ hematopoietic stem and progenitor cells with CD3+ T-cells Prevention of graft rejection following solid organ transplantation 06/25/2019 Designated
1398 CD4 human truncated 369 AA polypeptide Treatment of acquired immunodeficiency syndrome. 11/21/1989 Designated/Withdrawn
1399 CD4-mediated activated regulatory T cells Treatment of graft-versus-host disease 11/27/2017 Designated
1400 CD40/CD80/CD86 modified autologous dendritic cell therapy Treatment Type 1 diabetes mellitus patients with residual beta cell function 12/20/2013 Designated
1401 CD5-T lymphocyte immunotoxin Treatment of graft versus host disease and/or rejection in patients who have received bone marrow transplants. 08/27/1987 Designated/Withdrawn
1402 CDC-like kinase inhibitor of the Wnt Pathway Treatment of pancreatic cancer 12/17/2018 Designated
1403 Ceclazepide Treatment of gastric neuroendocrine tumors (gastric NETs). 05/12/2016 Designated
1404 cedazuridine and decitabine Treatment of myelodysplastic syndromes (including chronic myelomonocytic leukemia) 08/21/2019 Designated
1405 cediranib Treatment of glioblastoma 12/13/2010 Designated
1406 Ceftriaxone sodium Treatment of amyotrophic lateral sclerosis 03/28/2006 Designated
1407 Celecoxib oral liquid suspension Treatment of pediatric juvenile idiopathic arthritis 01/05/2017 Designated
1408 celiprolol Treatment of Ehlers-Danlos syndrome 01/05/2015 Designated
1409 cell based therapeutic composed of allogeneic donor apoptotic cells Prevention of graft versus host disease 03/18/2013 Designated
1410 Cell-penetrating activating transcription factor 5 mimetic Treatment of Acute Myeloid Leukemia 04/30/2018 Designated
1411 cell-penetrating CCAAT-enhancer-binding protein ß antagonist Treatment of Glioma 02/05/2020 Designated
1412 Cell-penetrating dominant-negative activating transcription factor 5 Treatment of glioma 03/20/2017 Designated/Withdrawn
1413 Cells produced using the AastromReplicelle System and SC-I Therapy Kit For use in patients receiving high dose chemotherapy who are unable to generate an acceptable dose of peripheral blood stem cells and who have a sufficient bone marrow aspirate without morphological evidence of tumor 07/10/2002 Designated
1414 cellspan esophageal implant Restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury, or congenital abnormality 11/29/2016 Designated
1415 cenegermin-bkbj Treatment of neurotrophic keratitis 06/23/2014 Designated/Approved
1416 cenersen Treatment of stage IIB through IV melanoma 06/18/2008 Designated
1417 cenersen Treatment of chronic lymphocytic leukemia 02/27/2008 Designated
1418 cenersen Treatment of acute myeloid leukemia 05/08/2006 Designated
1419 Centruroides immune F(ab)2 Treatment of scorpion envenomations requiring medical attention. 06/12/2000 Designated/Approved
1420 ceramide Treatment of Acute Myeloid Leukemia 12/18/2018 Designated
1421 ceramide Treatment of Pancreatic Cancer 11/13/2018 Designated
1422 ceramide Treatment of liver cancer 08/08/2016 Designated
1423 Ceramide trihexosidase/alpha-galactosidase A Treatment of Fabry's disease. 01/19/1988 Designated/Approved
1424 cerdulatinib Treatment of peripheral T-cell lymphoma (PTCL). 09/21/2018 Designated
1425 cereblon enzyme 3 (E3) ubiquitin ligase modulating agent Treatment of multiple myeloma 05/14/2019 Designated
1426 ceritinib Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive 09/27/2013 Designated/Approved
1427 ceritinib Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive 09/27/2013 Designated/Approved
1428 Cerium dioxide nanoparticles Treatment of Amyotrophic Lateral Sclerosis 03/26/2020 Designated
1429 cerliponase alfa Treatment of neuronal ceroid lipofuscinosis type 2 04/01/2013 Designated/Approved
1430 cethromycin Prophylactic treatment of tularemia due to Francisella tularensis. 09/09/2009 Designated
1431 cethromycin Prophylactic treatment of patients exposed to inhalation anthrax. 02/28/2007 Designated
1432 cethromycin Prophylactic treatment of plague due to Yersinia pestis 09/09/2009 Designated
1433 Cetiedil citrate injection Treatment of sickle cell disease crisis. 12/22/1988 Designated/Withdrawn
1434 cetuximab Treatment of pancreatic cancer 06/15/2007 Designated/Withdrawn
1435 cetuximab Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor 07/03/2000 Designated/Approved
1436 Chelating agent delivering Holmium-166 Treatment of multiple myeloma. 02/10/1999 Designated
1437 chelmab-y or chelamusab-Y Treatment of ovarian cancer. 04/24/1990 Designated
1438 chemically modified recombinant sulfamidase Treatment of mucopolysaccharidosis type IIIA (MPS IIIA) 06/28/2017 Designated
1439 Chenodeoxycholic acid Treatment of cerebrotendinous xanthomatosis 01/29/2004 Designated
1440 chenodeoxycholic acid Treatment of cerebrotendinous xanthomatosis 02/12/2007 Designated
1441 chenodiol For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age 09/21/1984 Designated/Approved
1442 chenodiol Treatment of cerebrotendinous xanthomatosis 03/22/2010 Designated
1443 Chimeric (human-murine) G250 IgG monoclonal antibody Treatment of renal cell carcinoma. 07/24/2000 Designated/Withdrawn
1444 chimeric Antigen Receptor (CAR) directed against the target protein CD5 Treatment of acute lymphoblastic leukemia 10/16/2017 Designated
1445 chimeric antigen receptor directed against the target protein CD4 lentivirally transfected T cells Treatment of peripheral T-cell lymphoma 07/28/2016 Designated
1446 chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2 Treatment of mucopolysaccharidosis III Type B (MPS IIIB, Sanfilippo Syndrome Type B) 11/25/2014 Designated
1447 Chimeric locked nucleic acid and ribonucleic-deoxyribonucleic antisense oligonucleotide specific for the human UBE3A-antisense transcript Treatment of Angelman syndrome 08/28/2019 Designated
1448 Chimeric M-T412 (human-murine) IgG monoclonal anti-CD4 Treatment of multiple sclerosis. 06/05/1991 Designated/Withdrawn
1449 chimeric monoclonal antibodies, c-alphaStx2 For treatment of shiga-toxin producing bacterial infection 10/04/2005 Designated
1450 chimeric monoclonal antibody against Claudin 6 Treatment of ovarian cancer 03/18/2013 Designated
1451 chimeric monoclonal antibody against claudin-18 splice variant 2 Treatment of pancreatic cancer 09/26/2013 Designated
1452 Chimeric monoclonal antibody to CD30 (anti-CD30 antibody) Treatment of CD30 positive T-cell lymphomas 02/18/2004 Designated/Withdrawn
1453 Chimeric monoclonal antibody to CD30 (anti-CD30 antibody) Treatment of Hodgkin's disease 07/18/2003 Designated/Withdrawn
1454 chimeric monoclonal antibody to claudin 18 splice variant 2 Treatment of gastric cancer 11/20/2012 Designated
1455 Chimeric monoclonal antibody to mesothelin Treatment of pancreatic cancer 10/31/2006 Designated/Withdrawn
1456 chimeric murine/human IgG1 monoclonal antibody to human interleukin-3 receptor alpha chain Treatment of acute myeloid leukemia 04/03/2009 Designated/Withdrawn
1457 Chimeric, humanized monoclonal antibody to staphylococcus Prophylaxis of Staphylococcus epidermidis sepsis in low birth weight (1500 grams or less) infants. 08/03/2000 Designated
1458 Chlorhexidine gluconate mouthrinse For use in the amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy. 08/18/1986 Designated
1459 chlorobutanol/propylene glycol/hydrochloric acid Treatment of patulous eustachian tube 02/18/1997 Designated
1460 chloropyramine Treatment of pancreatic cancer 10/22/2010 Designated
1461 chloroquine Treatment of glioblastoma multiforme. 05/20/2015 Designated
1462 chlorotoxin Treatment of stage IIb, IIc, III & IV melanoma 12/02/2008 Designated
1463 Chlorotoxin Treatment of malignant glioma 12/18/2007 Designated
1464 chlorotoxin conjugated to indocyanine green dye Diagnostic for the management of malignant brain tumors 06/23/2015 Designated
1465 cholera toxin B subunit Treatment of ulcerative colitis in pediatric patients 11/16/2017 Designated
1466 cholest-4-en-3-one, oxime Treatment of spinal muscular atrophy. 02/17/2009 Designated/Withdrawn
1467 cholesterol 24S-hydroxylase inhibitor Treatment of Dravet syndrome 11/29/2017 Designated
1468 cholesterol 24S-hydroxylase inhibitor Treatment of Lennox-Gastaut syndrome 12/06/2017 Designated
1469 cholic acid Treatment of inborn errors of cholesterol and bile acid synthesis and metabolism 07/18/2003 Designated/Approved
1470 Choline chloride Prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition 07/20/2006 Designated
1471 Choline chloride Treatment of choline deficiency, specifically the choline deficiency, hepatic steatosis, and cholestasis, associated with long-term parenteral nutrition. 02/10/1994 Designated
1472 choline tetrathiomolybdate Treatment of Wilson's disease 08/25/2011 Designated
1473 Chondrocyte-alginate gel suspension For use in correcting vesicoureteral reflux in the pediatric population. 12/01/1997 Designated
1474 Chondroitinase Treatment of patients undergoing vitrectomy. 02/09/1995 Designated/Withdrawn
1475 chromium picolinate and chromium histidinate Treatment of pediatic polycystic ovary syndrome (0 through 16 years of age) 12/22/2014 Designated
1476 chrysoeriol Treatment of acute myeloid leukemia 06/22/2017 Designated
1477 cicletanine hydrochloride Treatment for pulmonary arterial hypertension. 06/24/2008 Designated/Withdrawn
1478 Ciclopirox Treatment of congenital erythropoietic porphyria 04/17/2018 Designated
1479 cilengitide Treatment of malignant glioma 05/27/2005 Designated/Withdrawn
1480 Ciliary neurotrophic factor Treatment of amyotrophic lateral sclerosis. 01/30/1992 Designated
1481 Ciliary neurotrophic factor, recombinant human Treatment of spinal muscular atrophies. 04/02/1992 Designated/Withdrawn
1482 Ciliary neurotrophic factor, recombinant human Treatment of motor neuron disease (including amyotrophic lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy, and primary lateral sclerosis). 05/08/1992 Designated/Withdrawn
1483 cinacalcet Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery 04/30/2010 Designated/Approved
1484 cinacalcet Treatment of hypercalcemia in patients with parathyroid carcinoma 05/12/2003 Designated/Approved
1485 cinacalcet Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery 04/30/2010 Designated/Approved
1486 cinacalcet Treatment of secondary hyperparathyroidism (HPT) in pediatric patients with chronic kidney disease receiving dialysis 09/07/2016 Designated
1487 Cintredekin Besudotox Treatment of idiopathic pulmonary fibrosis 04/30/2010 Designated
1488 cintredekin besudotox Treatment of malignant glioma 11/02/2001 Designated/Withdrawn
1489 Cipargamin Treatment of malaria 07/27/2017 Designated
1490 cipargamin Treatment of malaria 05/01/2020 Designated
1491 ciprofloxacin The management of bronchiectasis 06/01/2011 Designated
1492 ciprofloxacin DPI Management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients 02/02/2010 Designated/Withdrawn
1493 ciprofloxacin dry powder inhaler Treatment of non-cystic fibrosis bronchiectasis 04/17/2014 Designated/Withdrawn
1494 cis-adamantane-2-spiro-3'-8'-4'-2'-(4'-morpholinyl)ethoxyphenyl-1',2,'4'-trioxaspiro4.5 decane mesylate Treatment of malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, or Plasmodium malariae 01/19/2010 Designated
1495 Cis-diamminedichloroplatinum (II) polyethylene glycol-polyglutamate (cis platinum PEG-pGlu) polymeric micelles Treatment of biliary tract carcinoma 07/27/2017 Designated
1496 Cisplatin Treatment of anal cancer 09/06/2016 Designated
1497 Cisplatin ChemoThin Wafer Treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity) 11/03/2015 Designated
1498 Cisplatin in liposomal formulation Treatment of osteosarcoma 03/20/2007 Designated
1499 Cisplatin loaded hyaluronate film for implant Treatment of mesothelioma 05/02/2017 Designated
1500 Cisplatin/epinephrine Treatment of metastatic malignant melanoma. 09/07/2000 Designated
1501 Cisplatin/epinephrine Treatment of squamous cell carcinoma of the head and neck. 04/03/2000 Designated
1502 citric acid monohydrate Treatment of acute-on-chronic liver failure 06/21/2017 Designated
1503 Citric acid, glucono-delta-lactone and magnesium carbonate Treatment of renal and bladder calculi of the apatite or struvite variety. 08/28/1989 Designated/Approved
1504 civamide Treatment of postherpetic neuralgia of the trigeminal nerve 12/09/2002 Designated
1505 civamide Treatment of postherpetic neuralgia. 02/17/2009 Designated
1506 Cladribine Treatment of acute myeloid leukemia. 07/20/1990 Designated/Withdrawn
1507 cladribine Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder 03/19/2015 Designated
1508 Cladribine Treatment of hairy cell leukemia. 11/15/1990 Designated/Approved
1509 Cladribine Treatment of the chronic progressive form of multiple sclerosis. 04/19/1994 Designated
1510 Cladribine Treatment of non-Hodgkin's lymphoma. 04/19/1993 Designated/Withdrawn
1511 cladribine Treatment of chronic lymphocytic leukemia 12/31/1990 Designated/Withdrawn
1512 clarithromycin, rifabutin, clofazimine Treatment of pediatric Crohn's disease. 04/26/2011 Designated
1513 clazakizumab Treatment of chronic antibody-mediated rejection in kidney transplant recipients 08/08/2019 Designated
1514 clazosentan Treatment of cerebral vasospasm following subarachnoid hemorrhage 02/16/2006 Designated
1515 clemizole Treatment of Dravet syndrome 04/19/2017 Designated
1516 clenbuterol Treatment of amyotrophic lateral sclerosis 10/02/2018 Designated
1517 clenbuterol Adjunctive therapy with enzyme replacement therapy in the treatment of Pompe disease 10/27/2014 Designated
1518 Clenbuterol Treatment of Pompe disease (glycogen storage disease type II) 01/09/2017 Designated
1519 clervonafusp alfa Treatment of Pompe Disease 10/04/2018 Designated
1520 Clindamycin Prevention of Pneumocystis carinii pneumonia in AIDS patients. 10/28/1988 Designated
1521 Clindamycin Treatment of Pneumocystis carinii pneumonia associated with AIDS patients. 10/28/1988 Designated
1522 Clindamycin hydrochloride Treatment of sarcoidosis 08/09/2006 Designated
1523 clobazam Treatment of Lennox-Gastaut Syndrome 12/18/2007 Designated/Approved
1524 clofarabine Treatment of acute lymphoblastic leukemia 02/07/2002 Designated/Approved
1525 clofarabine Treatment of acute myelogenous leukemia 03/14/2002 Designated
1526 clofarabine Treatment of acute myeloid leukemia 01/24/2019 Designated
1527 clofazimine Treatment of active tuberculosis 06/25/2014 Designated
1528 Clofazimine Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. 06/11/1984 Designated/Approved
1529 clofazimine Treatment of Pulmonary Nontuberculous Mycobacterial Infections 08/17/2018 Designated
1530 Clonazepam Treatment of hyperekplexia (startle disease). 08/04/1994 Designated
1531 Clonazepam Intranasal Spray Treatment of recurrent acute repetitive seizures 12/19/2007 Designated
1532 Clonidine For continous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients tolerant to, or unresponsive to, intraspinal opiates. 01/24/1989 Designated/Approved
1533 Clotrimazole Topical treatment of children and adults with pouchitis 06/14/2005 Designated
1534 Clotrimazole Treatment of Huntington's disease 03/13/2006 Designated
1535 Clotrimazole Treatment of sickle cell disease. 04/24/1995 Designated
1536 clotrimazole otic solution Treatment of fungal otitis externa (otomycosis) 05/10/2016 Designated
1537 CNDO-109-activated allogeneic natural killer cells Treatment of acute myeloid leukemia 06/18/2012 Designated
1538 Coagulation factor IX Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B. 06/27/1989 Designated/Approved
1539 Coagulation Factor IX (human) For use as replacement therapy in patients with hemophilia B for the prevention and control of bleeding episodes, and during surgery to correct defective hemostasis. 07/05/1990 Designated/Approved
1540 Coagulation Factor IX (recombinant) Treatment of hemophilia B. 10/03/1994 Designated/Approved
1541 coagulation factor IX (recombinant) Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding) 10/31/2012 Designated/Approved
1542 Coagulation factor IX (recombinant), Fc fusion protein Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease) 10/30/2008 Designated/Approved
1543 Coagulation Factor VIIa (Recombinant) Treatment of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX 07/16/2004 Designated/Approved
1544 Coagulation factor VIIa (recombinant) Prevention of bleeding episodes in Glanzmann's thrombasthenia 06/18/2004 Designated
1545 Coagulation Factor VIIa (Recombinant) Treatment of bleeding in patients experiencing intracranial hemorrhage. 10/03/2006 Designated/Withdrawn
1546 Coagulation factor VIIa (recombinant) Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX. 06/06/1988 Designated/Approved
1547 Coagulation factor VIIa (recombinant) Prevention of bleeding episodes in patients with hemophilia A or B, with or without inhibitors 06/18/2004 Designated/Approved
1548 Coagulation factor VIIa (recombinant) Treatment of bleeding episodes in patients with congenital factor VII deficiency 09/10/2004 Designated/Approved
1549 Coagulation factor VIIa (recombinant) Prevention of bleeding episodes in patients with congenital Factor VII deficiency 09/10/2004 Designated/Approved
1550 Coagulation factor VIIa (recombinant) Prevention of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX 07/21/2004 Designated/Approved
1551 coagulation factor VIIa (recombinant) Treatment of bleeding episodes in Glanzmann's thrombasthenia 06/18/2004 Designated/Approved
1552 Coagulation factor X (human) Treatment of hereditary factor X deficiency 11/08/2007 Designated/Approved
1553 Coagulation factor X (human) Treatment of hereditary factor X deficiency 11/08/2007 Designated/Approved
1554 Coagulation factor Xa (recombinant), inactivated-zhzo For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery 02/23/2015 Designated/Approved
1555 coagulation factor XIII A-subunit (recombinant) Prophylaxis of bleeding associated with congential factor XIII deficiency 11/06/2003 Designated/Approved
1556 cobicistat Treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients 06/15/2017 Designated/Approved
1557 cobicistat Treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients 06/15/2017 Designated/Approved
1558 cobimetinib Treatment of stage IIb, IIc, III, and IV melanoma with BRAFV600 mutation 01/31/2014 Designated/Approved
1559 cobiprostone Treatment of cystic fibrosis 11/14/2002 Designated/Withdrawn
1560 cobitolimod Treatment of ulcerative colitis in pediatric patients 08/08/2017 Designated
1561 coccidioidin SD Skin Test Antigen For the diagnosis of Coccidioidomycosis 12/19/2007 Designated/Approved
1562 Coenzyme Q10 Treatment of Huntington's disease 03/05/2001 Designated
1563 coenzyme Q10 and d-alpha-tocopherol Treatment of Friedreich's Ataxia. 03/14/2011 Designated
1564 colchicine Treatment of familial Mediterranean fever 09/25/2007 Designated/Approved
1565 Colchicine For arresting the progression of neurologic disability caused by chronic progressive multiple sclerosis. 12/09/1985 Designated/Withdrawn
1566 Colchicine Treatment of Behcet's Syndrome 09/25/2007 Designated
1567 Colfosceril palmitate, cetyl alcohol, tyloxapol 1. Prevention of hyaline membrane disease, also known as respiratory distress syndrome, in infants born at 32 weeks gestation or less 2. prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32 weeks gestation or less and in the treatment of established HMO at all gestational ages. 10/20/1989 Designated/Approved
1568 Colfosceril palmitate, cetyl alcohol, tyloxapol Treatment of adult respiratory distress syndrome. 01/11/1993 Designated/Withdrawn
1569 colistimethate sodium Treatment of respiratory infection in patients with Cystic Fibrosis 03/19/2020 Designated
1570 collagenase clostridium histolyticum Treatment of Peyronie's disease. 03/12/1996 Designated/Approved
1571 collagenase clostridium histolyticum Treatment of advanced (involutional or residual stage) Dupuytren's disease 05/23/1996 Designated/Approved
1572 Combination of an inactivated purified rabies virus (IPRV) and the PIKA adjuvant (Poly I:C, kanamycin and calcium) Treatment of hepatocellular carcinoma 10/13/2016 Designated
1573 combination of disulfiram and copper gluconate Treatment of glioblastoma multiforme. 05/18/2016 Designated
1574 Combination of nivolumab and ipilimumab Treatment of Stage IIb to Stage IV melanoma 10/09/2014 Designated/Approved
1575 combination of p-Tolylmethylcarbinol nicotinic acid ester and a-naphthylacetic acid Treatment of primary biliary cholangitis 03/30/2020 Designated
1576 combination of sodium phenylbutyrate and tauroursodeoxycholic acid dihydrate Treatment of amyotrophic lateral sclerosis (ALS) 07/27/2017 Designated
1577 combinatorial regimen of LV305 (lentiviral vector encoding NY-ESO-1 gene) and G305 (NY-ESO-1 recombinant protein plus GLA-SE) Treatment of soft tissue sarcoma 05/02/2016 Designated/Withdrawn
1578 combretastatin A 1 diphosphate Treatment of acute myelogenous leukemia 11/19/2012 Designated
1579 Combretastatin A4 Phosphate Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and stage IV papillary or follicular thyroid cancer 07/23/2003 Designated
1580 Combretastatin A4 phosphate Treatment of ovarian cancer 05/08/2006 Designated
1581 competetive small molecule inhibitor of the enzyme O-GlcNAcase Treatment of progressive supranuclear palsy. 03/10/2016 Designated/Withdrawn
1582 competitive and reversible small molecule inhibitor of the O-linked-B-N-acetylglucosaminidase enzyme Treatment of progressive supranuclear palsy 07/10/2018 Designated
1583 complement factor H Treatment of atypical hemolytic uremic syndrome associated with an inherited abnormality of the complement system 12/07/2009 Designated/Withdrawn
1584 concizumab Treatment of hemophilia B 07/22/2019 Designated
1585 concizumab Treatment of hemophilia A 10/22/2018 Designated
1586 conditionally active biologics-anti-ROR2-antibody drug conjugate consisting of a humanized IgG1 antibody specific for ROR2 tyrosine kinase conjugated to a peptide linker coupled with monomethyl auristatin E Treatment of soft tissue sarcoma 12/18/2018 Designated
1587 Conjugate of a dengue virus specific small chemical ligand and an amphiphilic PEG based polymer Treatment of dengue fever (includes dengue hemorrhagic fever and dengue shock syndrome) 08/06/2013 Designated
1588 conjugate of human transferrin and a mutant diphtheria toxin (CRM 107) Treatment of malignant tumors of the central nervous system 12/03/2001 Designated
1589 conjugated bile acids Treatment of steatorrhea in patients with short bowel syndrome 07/18/2003 Designated
1590 Contulakin-G Intrathecal treatment of neuropathic pain associated with spinal cord injury 07/07/2005 Designated
1591 copanlisib Treatment of extranodal marginal zone lymphoma 02/07/2017 Designated
1592 copanlisib Treatment of nodal marginal zone lymphoma 02/07/2017 Designated
1593 copanlisib Treatment of splenic marginal zone lymphoma 02/07/2017 Designated
1594 copanlisib Treatment of follicular lymphoma 02/05/2015 Designated/Approved
1595 Copper 64-DOTA-TATE Diagnostic for the management of neuroendocrine tumors. 05/18/2016 Designated
1596 copper histidinate Treatment of Menkes disease 05/14/2012 Designated
1597 copper sulfate Treatment of keratoconus 10/26/2017 Designated
1598 Cordycepin Treatment of TdT-positive acute lymphocytic leukemia 07/05/2007 Designated
1599 corifungin Treatment of visceral leishmaniasis 07/06/2011 Designated
1600 corifungin Treatment of amebic meningoencephalitis. 08/22/2011 Designated
1601 Corticorelin ovine triflutate For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome. 11/24/1989 Designated/Approved
1602 corticotropin releasing factor 1 receptor antagonist Treatment of congenital adrenal hyperplasia 03/15/2019 Designated
1603 corticotropin-releasing factor receptor-1 antagonist containing an unfused thiazole ring Treatment of congenital adrenal hyperplasia 11/08/2017 Designated
1604 Corticotropin-releasing factor, human Treatment of peritumoral brain edema. 04/06/1998 Designated
1605 cosyntropin Treatment of Duchenne muscular dystrophy. 07/06/2017 Designated
1606 cosyntropin Treatment of infantile spasms. 08/02/2017 Designated
1607 cotsiranib Treatment of cholangiocarcinoma (CCA) 11/29/2017 Designated
1608 Cotsiranib Treatment of primary sclerosing cholangitis 06/15/2017 Designated
1609 Coumarin Treatment of renal cell carcinoma. 12/22/1994 Designated
1610 Coversin Treatment of paroxysmal nocturnal hemoglobinuria 09/08/2016 Designated
1611 Coxsackievirus A21 Treatment of stage II (T4), stage III, and stage IV melanoma 12/15/2005 Designated
1612 Creatine Treatment of Huntington's disease 10/11/2005 Designated/Withdrawn
1613 creatine Treatment of amyotrophic lateral sclerosis 02/12/2002 Designated
1614 crenolanib Treatment of acute myelogenous leukemia 10/31/2012 Designated
1615 crenolanib Treatment of gastric cancer, including cancer of the gastroesophageal junction 10/21/2019 Designated
1616 crenolanib Treatment of soft tissue sarcoma 03/18/2011 Designated
1617 crenolanib besylate Treatment of malignant glioma 12/20/2010 Designated
1618 cridanimod Treatment of progesterone receptor negative endometrial cancer in conjunction with progesterone therapy. 01/12/2011 Designated
1619 crizanlizumab Treatment of sickle cell disease 07/22/2008 Designated/Approved
1620 crizotinib Treatment of anaplastic large cell lymphoma 09/28/2012 Designated
1621 crizotinib Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer 09/13/2010 Designated/Approved
1622 crizotinib Treatment of neuroblastoma 10/31/2012 Designated
1623 crizotinib Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer 09/13/2010 Designated/Approved
1624 crofelemer Treatment of short bowel syndrome 08/02/2017 Designated
1625 Cromolyn sodium Treatment of mastocytosis. 03/08/1984 Designated/Approved
1626 Cromolyn sodium 4% ophthalmic solution Treatment of vernal keratoconjunctivitis. 07/24/1985 Designated/Approved
1627 cromolyn sodium for inhalation Treatment of mastocytosis. 12/09/2015 Designated
1628 cromolyn solution Treatment of idiopathic pulmonary fibrosis 04/11/2019 Designated
1629 cryopreserved human umbilical cord Treatment of spina bifida 01/08/2018 Designated
1630 Cryptosporidium hyperimmune bovine colostrum IgG concentrate Treatment of diarrhea in AIDS patients caused by infection with Cryptosporidium parvum. 12/30/1991 Designated
1631 CT-2584 mesylate Treatment of malignant mesothelioma. 04/16/1999 Designated/Withdrawn
1632 CT-2584 Mesylate Treatment of adult soft tissue sarcoma. 04/16/1999 Designated/Withdrawn
1633 Cultured human retinal pigment epithelial cell line (ARPE-19) genetically modified with a non-viral vector to express B domain deleted human factor VIII protein, encapsulated within two-layer modified alginate spheres Treatment of Hemophilia A 08/21/2019 Designated
1634 cultured skin substitute (CSS) Treatment of burns requiring skin grafting. 08/22/2016 Designated
1635 cultured, partially T-Cell depleted, allogeneic thymic tissue for transplantation Treatment of congenital athymia 08/15/2003 Designated
1636 cusatuzumab Treatment of acute myeloid leukemia 01/14/2019 Designated
1637 cyclic pyranopterin monophosphate (cPMP) Treatment of molybdenum cofactor deficiency type A (MoCD) 11/05/2009 Designated
1638 [[Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobytyrl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl}]] Treatment and chronic control of non-infectious posterior, intermediate and pan-uveitis 12/20/2006 Designated
1639 Cyclo(-L-Glycyl-L-2-Allylproline) Treatment of Phelan-McDermid syndrome 10/15/2019 Designated
1640 cyclo(-L-Glycyl-L-2-Allylproline) Treatment of Angelman syndrome 10/09/2019 Designated
1641 Cyclo(-L-Glycyl-L-2-Allylproline) Treatment of Pitt-Hopkins Syndrome 10/15/2019 Designated
1642 cyclo(-y-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonly-L-phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt Treatment of acromegaly 06/24/2013 Designated
1643 cyclocreatine Treatment of creatine transporter deficiency 06/18/2012 Designated
1644 cyclocreatine phosphate Prevention of ischemic injury to enhance cardiac graft recovery and survival in heart transplantation. 01/17/2018 Designated
1645 cyclophosphamide Treatment of systemic sclerosis. 06/07/2011 Designated
1646 cyclophosphamide Prevention of graft versus host disease following allogeneic hematopoietic stem cell transplant 06/17/2011 Designated
1647 Cyclosporin A Treatment of amyotrophic lateral sclerosis and its variants 10/29/2004 Designated
1648 Cyclosporine Prophylaxis of organ rejection in patients receiving allogeneic lung transplant 11/25/2003 Designated
1649 cyclosporine Treatment of graft-versus-host disease 02/17/2009 Designated/Withdrawn
1650 cyclosporine Prophylaxis of graft-versus-host disease 02/17/2009 Designated/Withdrawn
1651 Cyclosporine Treatment of acute rejection in patients requiring allogenic lung transplants 11/25/2003 Designated
1652 cyclosporine 2% ophthalmic ointment For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer 08/01/1991 Designated
1653 cyclosporine 2% ophthalmic ointment Treatment of patients at high risk of graft rejection following penetrating keratoplasty 08/01/1991 Designated
1654 cyclosporine A Prevention of corneal graft rejection 09/30/2008 Designated
1655 cyclosporine A Treatment of herpes simplex virus stromal keratitis 04/09/2008 Designated
1656 Cyclosporine A Treatment of vernal keratoconjunctivitis 05/04/2007 Designated
1657 Cyclosporine A implant For the prevention of acute rejection in cornea transplant patients 01/08/2007 Designated/Withdrawn
1658 Cyclosporine in combination with omega-3 polyunsaturated fatty acids Prevention of solid organ graft rejection. 12/06/2000 Designated
1659 Cyclosporine ophthalmic Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome. 11/09/1988 Designated
1660 cyclosporine; ciclosporin Treatment of moderate to severe traumatic brain injury. 11/23/2010 Designated
1661 [[Cyclo{-Asn-Leu-d-Phe-Al(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)-} . Al(III)]] Treatment of invasive aspergillosis. 12/29/2015 Designated
1662 Cyproterone acetate Treatment of severe hirsutism. 10/26/1984 Designated/Withdrawn
1663 Cys-His-Ala-Val-Cys For use in conjunction with melphalen for the treatment of malignant melanoma, AJCC stages IIB, IIC, III and IV 02/14/2008 Designated
1664 cysteamine Treatment of Huntington's disease 05/09/2008 Designated
1665 cysteamine Treatment of pancreatic cancer 09/11/2013 Designated
1666 cysteamine Treatment of neuronal ceroid lipofuscinoses (Batten disease) 08/06/2008 Designated
1667 Cysteamine Treatment of nephropathic cystinosis. 05/01/1986 Designated
1668 Cysteamine Treatment of cystic fibrosis 09/11/2014 Designated
1669 Cysteamine Treatment of nephropathic cystinosis. 01/25/1991 Designated/Approved
1670 cysteamine enteric coated Treatment of cystinosis 10/24/2006 Designated/Approved
1671 cysteamine enteric coated Treatment of cystinosis 10/24/2006 Designated/Approved
1672 cysteamine enteric coated Treatment of cystinosis 10/24/2006 Designated/Approved
1673 cysteamine enteric coated Treatment of cystinosis 10/24/2006 Designated/Approved
1674 Cysteamine hydrochloride Treatment of corneal cystine crystal accumulation in cystinosis patients. 08/19/1997 Designated/Approved
1675 Cystic fibrosis gene therapy Treatment of cystic fibrosis. 06/30/1992 Designated/Withdrawn
1676 Cystic fibrosis Tr gene therapy (recombinant adenovirus) Treatment of cystic fibrosis. 03/09/1995 Designated
1677 Cystic fibrosis transmembrane conductance regulator For cystic fibrosis transmembrane conductance regulator protein replacement therapy in cystic fibrosis patients. 01/14/1992 Designated/Withdrawn
1678 Cystic fibrosis transmembrane conductance regulator gene Treatment of cystic fibrosis. 01/08/1993 Designated
1679 Cytarabine liposomal Treatment of neoplastic meningitis. 06/02/1993 Designated/Approved
1680 cytarabine liposome Treatment of gliomas 01/30/2007 Designated
1681 cytarabine-beta-L-aspartic acid Treatment of Acute Myeloid Leukemia 05/14/2019 Designated
1682 Cytarabine:daunorubicin liposome injection Treatment of acute myeloid leukemia 08/22/2008 Designated/Approved
1683 cytochrome C, flavin mononucleotide and thiamin diphosphate Treatment of mitochondrial disorders 06/17/2011 Designated
1684 cytochrome P450 isoform 2B1 gene transfected human embryonic kidney 293 cells encapsulated in polymeric cellulose sulphate Treatment of pancreatic cancer in combination with ifosfamide 12/17/2014 Designated
1685 Cytomegalovirus DNA Vaccine w/Copolymer/Benzalkonium Chloride For use in prevention of clinically significant CMV viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid organ transplant populations 09/23/2006 Designated
1686 Cytomegalovirus DNA vaccine with plasmids expressing pp65 and gB genes Prevention of clinically significant cytomegalovirus (CMV) viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid transplant populations 06/03/2005 Designated
1687 Cytomegalovirus immune globulin (human) Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants. 08/03/1987 Designated/Approved
1688 Cytomegalovirus immune globulin intravenous (human) For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients. 01/28/1991 Designated
1689 cytomegalovirus specific cytotoxic T lymphocytes Treatment of cytomegalovirus infection in severely immunocompromised patients 01/05/2017 Designated
1690 D-amino acid oxidase inhibitor Treatment of Friedreich's ataxia (FRDA) 12/06/2017 Designated/Withdrawn
1691 D-Galactose Treatment of Phosphoglucomutase 1 Deficiency 01/14/2019 Designated
1692 D-mannitol and L-proline Treatment of Cockayne syndrome 04/20/2009 Designated
1693 D-mannose Treatment of Mannose Phosphate Isomerase Deficiency 01/14/2019 Designated
1694 d-methadone Treatment of postherpetic neuralgia 06/02/2016 Designated
1695 D-peptide Treatment of acute myelogenous leukemia 02/04/2011 Designated
1696 D-peptide of the sequence AKRHHGYKRKFH - NH2 Treatment of cystic fibrosis 10/23/2002 Designated
1697 D-Phe-Cys-Tyr-D-Trp-Lys-Cys-Thr-Nh2 (disulfide bridge: 2-6) acetate Treatment of melanoma, stages IIb through IV 03/19/2009 Designated/Withdrawn
1698 D-tagatose Treatment of Prader-Willi Syndrome 01/19/2017 Designated
1699 d6-tetrabenazine, deutetrabenazine Treatment of Huntington's Disease 11/05/2014 Designated/Approved
1700 D9-ivacaftor Treatment of cystic fibrosis (CF) 01/18/2017 Designated
1701 dabrafenib Treatment BRAF V600 mutation positive Stage IIB through IV melanoma 01/12/2011 Designated/Approved
1702 dabrafenib Treatment of patients with BRAF mutation positive non-small cell lung cancer 10/20/2014 Designated
1703 dabrafenib Treatment of malignant glioma with BRAF V600 mutation 02/08/2016 Designated
1704 dabrafenib and trametinib Treatment of patients with anaplastic thyroid cancer and locally advanced or metastatic papillary thyroid cancer whose tumors harbor a BRAF V600 mutation. 09/01/2016 Designated/Approved
1705 dabrafenib and trametinib Treatment of patients with anaplastic thyroid cancer and locally advanced or metastatic papillary thyroid cancer whose tumors harbor a BRAF V600 mutation. 09/01/2016 Designated/Approved
1706 dabrafenib and trametinib Treatment of patients with BRAF mutation positive non-small cell lung cancer. 10/29/2015 Designated/Approved
1707 dacetuzumab Treatment of multiple myeloma. 08/13/2004 Designated
1708 dacetuzumab Treatment of chronic lymphocytic leukemia 10/06/2005 Designated
1709 Daclizumab Prevention of acute renal allograft rejection. 03/05/1993 Designated/Approved
1710 dacomitinib Treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations. 03/03/2015 Designated/Approved
1711 dalbavancin Treatment of acute osteomyelitis in children (0 through 16 years of age) 03/30/2015 Designated
1712 Dalcinonacog Alfa Treatment for hemophilia B 09/20/2017 Designated
1713 dalfampridine Relief of symptoms of multiple sclerosis 06/02/1987 Designated/Approved
1714 dalfampridine Treatment of Transverse Myelitis 11/25/2019 Designated
1715 dantrolene Treatment of organophosphate exposure 12/12/2019 Designated
1716 Dantrolene sodium Treatment of the neuroleptic malignant syndrome. 12/14/1987 Designated/Withdrawn
1717 dantrolene sodium Treatment of heat stroke 09/25/2012 Designated
1718 dantrolene sodium Treatment of Wolfram Syndrome 02/17/2016 Designated
1719 dantrolene sodium suspension for injection Treatment of malignant hyperthermia syndrome 08/16/2013 Designated/Approved
1720 Dapsone Prophylaxis of toxoplasmosis in severely immunocompromised patients with CD4 counts below 100. 11/07/1994 Designated
1721 Dapsone USP For the combination treatment of Pneumocystis carinii pneumonia in conjunction with trimethoprim. 01/08/1992 Designated
1722 Dapsone USP Prophylaxis for Pneumocystis carinii pneumonia. 12/24/1991 Designated
1723 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1724 daratumumab Treatment of mantle cell lymphoma. 08/20/2015 Designated
1725 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1726 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1727 daratumumab Treatment of follicular lymphoma 08/06/2015 Designated
1728 daratumumab Treatment of systemic amyloid light-chain (AL) amyloidosis 09/05/2017 Designated
1729 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1730 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1731 daratumumab Treatment of diffuse large B-cell lymphoma. 11/09/2015 Designated
1732 daratumumab Treatment of multiple myeloma 05/06/2013 Designated/Approved
1733 Darinaparsin Treatment of peripheral T-cell lymphoma. 09/13/2010 Designated
1734 Daromun Treatment of Melanoma Stages IIb through IV. 07/10/2018 Designated
1735 dasatinib Treatment of chronic myelogenous leukemia 11/28/2005 Designated/Approved
1736 dasatinib Treatment of chronic myelogenous leukemia 11/28/2005 Designated/Approved
1737 Dasatinib Treatment of Philadelphia-positive acute lymphoblastic leukemia 11/18/2005 Designated/Approved
1738 Dasatinib Treatment of Philadelphia-positive acute lymphoblastic leukemia 11/18/2005 Designated/Approved
1739 dasiglucagon Treatment of hypoglycemia in patients with congenital hyperinsulinism (CH) 08/10/2017 Designated
1740 dasiprotimut-T Treatment of mantle cell lymphoma 06/17/2010 Designated
1741 dasiprotimut-T Treatment of follicular lymphoma 10/28/2009 Designated
1742 daunorubicin citrate liposome Treatment of acute myeloid leukemia 04/15/2013 Designated/Withdrawn
1743 Daunorubicin citrate liposome injection Treatment of patients with advanced HIV-associated Kaposi's sarcoma. 05/14/1993 Designated/Approved
1744 Daunorubicin liposomal Treatment of acute myeloid leukemia 09/05/2008 Designated
1745 davunetide Treatment of Activity-Dependent Neuroprotective Protein (ADNP) Syndrome 02/22/2018 Designated
1746 davunetide Treatment of progressive supranuclear palsy. 12/07/2009 Designated
1747 daxibotulinumtoxinA Treatment of cervical dystonia 11/16/2017 Designated
1748 DCVAC OvCa Treatment of ovarian cancer 05/14/2013 Designated
1749 DEAE-rebeccamycin Treatment of bile duct tumors 03/01/2004 Designated
1750 debrase Debridement of acute, deep dermal burns in hospitalized patients 08/20/2003 Designated
1751 decitabine Treatment of myelodysplastic syndromes. 03/08/1999 Designated/Approved
1752 decitabine Treatment of chronic myelogenous leukemia. 03/08/1999 Designated/Withdrawn
1753 decitabine Treatment of acute myeloid leukemia 08/04/2006 Designated/Withdrawn
1754 decitabine Treatment of sickle cell anemia 09/09/2002 Designated/Withdrawn
1755 decitabine and tetrahydrouridine Treatment of sickle cell disease 09/19/2016 Designated
1756 defactinib Treatment of ovarian cancer 02/12/2015 Designated
1757 deferasirox Treatment of chronic iron overload in alpha-thalassemia 02/24/2015 Designated/Approved
1758 Deferasirox Treatment of chronic iron overload in patients with transfusion-dependent anemias 11/21/2002 Designated/Approved
1759 deferasirox Treatment of chronic iron overload in alpha-thalassemia 02/24/2015 Designated/Approved
1760 Deferasirox Treatment of chronic iron overload in patients with transfusion-dependent anemias 11/21/2002 Designated/Approved
1761 deferiprone Treatment of superficial siderosis 09/01/2011 Designated
1762 deferiprone Treatment of Friedreich's ataxia 07/31/2008 Designated
1763 deferiprone Treatment of neurodegeneration with brain iron accumulation (NBIA) 06/15/2017 Designated
1764 deferiprone Treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy 12/12/2001 Designated/Approved
1765 deferiprone Treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy 12/12/2001 Designated/Approved
1766 Deferitrin Treatment of iron overload 04/14/2004 Designated/Withdrawn
1767 deferoxamine Treatment of sickle cell leg ulcers 03/15/2019 Designated
1768 deferoxamine starch conjugate Treatment of chronic iron overload resulting from conventional transfusional treatment of beta-thalassemia major and sickle cell anemia. 12/21/1998 Designated
1769 deferoxamine starch conjugate Treatment of acute iron poisoning 01/28/2005 Designated
1770 defibrotide For the prevention of hepatic veno-occlusive disease. 01/08/2007 Designated
1771 Defibrotide Treatment of thrombotic thrombocytopenic purpura. 07/05/1985 Designated
1772 defibrotide For the treatment of hepatic veno-occlusive disease 05/21/2003 Designated/Approved
1773 defibrotide Prevention of acute graft versus host disease 05/14/2020 Designated
1774 deflazacort Treatment of Duchenne muscular dystrophy 08/16/2013 Designated/Approved
1775 deflazacort Treatment of Duchenne muscular dystrophy 08/16/2013 Designated/Approved
1776 deflazacort Treatment of Duchenne muscular dystrophy 09/16/2010 Designated
1777 deflazacort Treatment of pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) International League of Associations for Rheumatology (ILAR) categories excluding systemic JIA. 10/22/2015 Designated/Withdrawn
1778 dehydrated alcohol Treatment of trigeminal neuralgia 03/16/2012 Designated
1779 dehydrated alcohol Treatment of hypertrophic obstructive cardiomyopathy 09/11/2013 Designated/Approved
1780 Dehydroepiandrosterone Treatment of systemic lupus erythematosus (SLE) and the reduction in the use of steroids in steroid-dependent SLE patients. 07/13/1994 Designated/Withdrawn
1781 Dehydroepiandrosterone (DHEA) Replacement therapy in individuals with adrenal insufficiency 08/19/2003 Designated
1782 Dehydroepiandrosterone sulfate sodium To accelerate the re-epithelialization of donor sites in those hospitalized burn patients who must undergo autologous skin grafting. 01/28/1997 Designated
1783 Dehydroepiandrosterone sulfate sodium Treatment of serious burns requiring hospitalization. 01/29/1997 Designated
1784 delta-9-tetrahydrocannabinol Treatment of Hepatocellular Carcinoma 11/27/2019 Designated
1785 delta-9-tetrahydrocannabinol and cannabidiol Treatment of complex regional pain syndrome 03/07/2018 Designated
1786 delta-9-tetrahydrocannabinol and cannabidiol Treatment of Epidermolysis Bullosa 04/14/2020 Designated
1787 delta-9-tetrahydrocannabinol and cannabidiol Treatment of Huntington's Disease 01/29/2019 Designated
1788 delta-9-tetrahydrocannibinol and cannabidiol Treatment of glioma. 12/03/2015 Designated
1789 demcizumab Treatment of pancreatic cancer 04/30/2014 Designated/Withdrawn
1790 Dendritic cell/tumor cell fusion vaccine + recombinant human interleukin 12 Treatment of malignant glioma 01/25/2017 Designated
1791 dendritic cells pulsed with synthetic peptides derived from antigens MAGE1, HER-2, AIM-2,TRP-2, gp100 and interleukin-13 receptor alpha Treatment of glioblastoma or brain stem glioma 06/07/2010 Designated
1792 dendritic hybrid cell vaccine Treatment of neuroblastoma 09/23/2011 Designated
1793 dendritic-cell targeting, lentiviral vector encoding the NY-ESO-1 gene Treatment of soft tissue sarcoma. 01/06/2016 Designated/Withdrawn
1794 denileukin diftitox Treatment of peripheral T-cell lymphoma (PTCL) 06/29/2011 Designated
1795 denileukin diftitox Treatment of cutaneous T-cell lymphoma 07/12/2013 Designated
1796 denileukin diftitox Treatment of patients with cutaneous T-cell lymphoma 08/21/1996 Designated/Approved
1797 denileukin diftitox Treatment of peripheral T-cell lymphoma 04/30/2010 Designated
1798 denosumab Treatment of hypercalcemia in malignancy 09/11/2013 Designated/Approved
1799 denosumab Treatment of patients with giant cell tumor of bone 12/20/2010 Designated/Approved
1800 deoxynucleogen Treatment of pancreatic cancer 09/10/2019 Designated
1801 deoxythymidine monophosphate and deoxycytidine monophosphate Treatment of thymidine kinase 2 deficiency. 07/07/2016 Designated
1802 Dermagraft Treatment of epidermolysis bullosa 12/13/2010 Designated
1803 Deslorelin Treatment of central precocious puberty. 11/05/1987 Designated
1804 Desmoglein 3 synthetic peptide (PI-0824) Treatment of pemphigus vulgaris 10/26/2004 Designated
1805 Desmopressin acetate Treatment of mild hemophilia A and von Willebrand's disease. 01/22/1991 Designated/Approved
1806 deuterated S-lisofylline Treatment of Necrobiosis Lipoidica 06/18/2018 Designated
1807 deutetrabenazine Treatment of Tourette syndrome in the pediatric population (defined as 0 through 16 years of age) 01/13/2015 Designated
1808 dexamethasone Treatment of multiple myeloma (MM) 03/26/2018 Designated/Approved
1809 dexamethasone Treatment of multiple myeloma 02/26/2019 Designated
1810 dexamethasone intravitreal implant Treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate, posterior, and panuveitis 09/11/1998 Designated/Approved
1811 dexamethasone phosphate Treatment of corneal graft rejection. 12/02/2008 Designated
1812 dexamethasone sodium phosphate encapsulated in autologous erythrocytes Treatment of ataxia-telangiectasia 07/24/2012 Designated
1813 dexanabinol For the attenuation or amelioration of the long-term neurological sequelae associated with moderate and severe traumatic brain injury 08/11/2004 Designated
1814 dexpramipexole Treatment of amyotrophic lateral sclerosis 10/11/2007 Designated
1815 Dexpramipexole Treatment of hypereosinophilic syndrome (HES) 04/22/2019 Designated
1816 Dexrazoxane For the prevention of cardiomyopathy associated with doxorubicin administration. 12/17/1991 Designated/Approved
1817 dexrazoxane Treatment of anthracycline extravasation during chemotherapy 03/25/2004 Designated/Approved
1818 dexrazoxane hydrochloride Prevention of cardiomyopathy for chilren and adolescents 0 through 16 years of age treated with anthracyclines 08/19/2014 Designated
1819 dextran 1 Treatment of cystic fibrosis 03/21/2003 Designated
1820 Dextran 70 Treatment of recurrent corneal erosion unresponsive to conventional therapy. 03/05/1990 Designated
1821 Dextran and deferoxamine Treatment of acute iron poisoning. 03/08/1991 Designated
1822 Dextran sulfate (inhaled, aerosolized) For use as an adjunct to the treatment of cystic fibrosis. 10/05/1990 Designated
1823 Dextran sulfate sodium Treatment of aquired immunodeficiency syndrome. 11/19/1987 Designated
1824 dextromethorphan hydrobromide/quinidine sulfate Treatment of amyotrophic lateral sclerosis (ALS) 02/14/2017 Designated
1825 DHA-paclitaxel Treatment of pancreatic cancer 09/25/2001 Designated/Withdrawn
1826 DHA-paclitaxel Treatment of metastatic malignant melanoma 10/10/2002 Designated/Withdrawn
1827 DHA-paclitaxel Treatment of adenocarcinoma of the stomach or lower esophagus 05/01/2003 Designated/Withdrawn
1828 di-deuterated linoleic acid Treatment of Progressive Supranuclear Palsy 01/28/2020 Designated
1829 Diacerein Treatment of epidermolysis bullosa 11/02/2018 Designated
1830 diacerein Treatment of epidermolysis bullosa 10/15/2014 Designated
1831 diacetyl(N(4)-methylthiosemicarbazonato) copper (II) Treatment of amyotrophic lateral sclerosis (ALS) 12/18/2017 Designated
1832 Dianeal peritoneal dialysis solution with 1.1% amino acids For use as a nutritional supplement for the treatment of malnourishment in patients undergoing continuous ambulatory peritoneal dialysis. 06/11/1992 Designated
1833 diannexin Prevention of ischemia-reperfusion injury in solid organ transplants 10/28/2009 Designated
1834 diazepam Treatment of Dravet syndrome 05/23/2018 Designated
1835 diazepam (intranasal) Management of patients with acute repetitive seizures 07/31/2012 Designated
1836 diazepam (intranasal) Management of acute repetitive seizures 11/16/2015 Designated/Approved
1837 diazepam auto-injector Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity 05/30/2013 Designated
1838 diazepam buccal soluble film Treatment of selected, refractory patients with epilepsy who are on stable regimens of antiepileptic drugs (AED) and who require intermittent use of diazepam to control bouts of increased seizure activity (acute repetitive seizures) 11/10/2016 Designated
1839 diazepam subcutaneous injection Treatment of acute repetitive seizures. 05/26/2016 Designated
1840 Diazepam viscous solution for rectal administration For the management of selected, refractory, patients with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity. 02/25/1992 Designated/Approved
1841 Diaziquone Treatment of primary brain malignancies (grade III and IV astrocytomas). 11/10/1983 Designated/Withdrawn
1842 diazoxide Treatment of Prader Willi Syndrome 12/03/2012 Designated
1843 diazoxide choline Treatment of Prader-Willi Syndrome 05/13/2014 Designated
1844 dichlorphenamide Treatment of primary periodic paralyses 09/02/2010 Designated/Approved
1845 Dideoxyinosine Treatment of acquired immunodeficiency syndrome. 06/22/1988 Designated/Withdrawn
1846 Diethyldithiocarbamate Treatment of AIDS. 04/03/1986 Designated
1847 diethylenetriaminepentaacetate (DPTA) For treatment of patients with known or suspected internal contamination with plutonium, americium or curium to increase the rates of elimination. 04/14/2004 Designated
1848 Diethylenetriaminepentaacetic acid (DTPA) Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination. 04/28/2004 Designated/Approved
1849 Diethylnorspermine (DENSPM) Treatment for hepatocellular carcinoma 05/25/2004 Designated/Withdrawn
1850 diferuloylmethane Treatment of cystic fibrosis 06/13/2003 Designated/Withdrawn
1851 difluprednate Treatment of endogenous and traumatic anterior uveitis and panuveitis. 09/30/2008 Designated/Approved
1852 digitoxin Treatment of ovarian cancer 11/02/2001 Designated
1853 digitoxin Treatment of cystic fibrosis 05/27/2005 Designated
1854 digitoxin Treatment of soft tissue sarcomas 10/18/2001 Designated
1855 Digoxin immune FAB (Ovine) Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy. 11/01/1984 Designated/Approved
1856 digoxin immune fab (ovine) Treatment of severe preeclampsia and eclampsia 02/03/2012 Designated
1857 Digoxin immune fab(ovine) Treatment of life-threatening acute cardiac glycoside intoxication manifested by conduction disorders, ectopic ventricular activity and (in some cases) hyperkalemia. 03/11/1985 Designated
1858 dihydroartemisinin and piperaquine Treatment of uncomplicated malaria caused by "Plasmodium falciparum," Plasmodium vivax," Plasmodium malariae," or "Plasmodium ovale." 01/08/2007 Designated
1859 Dihydrotestosterone Treatment of weight loss in AIDS patients with HIV-associated wasting. 02/05/1996 Designated
1860 dihydroxyphenylalanine F 18/Fluorodopa (F18) Diagnostic for the management of congenital hyperinsulinism 01/22/2018 Designated
1861 Dilanubicel Reduction of morbidity and mortality associated with hematopoietic stem cell transplantation 07/09/2018 Designated
1862 dimebon Treatment of Huntington's Disease. 05/12/2009 Designated
1863 Dimerizing drug that binds to mutated Fas protein/drug-binding domain fusion protein (FKBP) Treatment of acute graft-versus-host disease in patients undergoing bone marrow transplantation. 11/24/1999 Designated
1864 dimethyl fumarate Treatment of Friedreich's Ataxia 09/11/2013 Designated
1865 Dimethyl sulfoxide Treatment of cutaneous manifestations of scleroderma. 06/06/1986 Designated/Withdrawn
1866 dimethyl sulfoxide For use in combination with antimicrobial drugs for the treatment of drug resistant tuberculosis 05/09/2008 Designated
1867 Dimethyl sulfoxide Treatment of increased intracranial pressure in patients with severe, closed-head injury, also known as traumatic brain coma, for whom no other effective treatment is available. 11/22/1994 Designated
1868 Dimethylsulfoxide Topical treatment for the prevention of soft tissue injury following extravastion of cytotoxic drugs. 04/15/1997 Designated
1869 Dimethylsulfoxide Treatment of palmar-plantar erythrodysethesia syndrome. 04/06/1998 Designated
1870 dinaciclib Treatment of chronic lymphocytic leukemia. 08/25/2011 Designated
1871 dinutuximab Treatment of neuroblastoma 12/20/2010 Designated/Approved
1872 diosmin Treatment of systemic sclerosis 05/15/2018 Designated
1873 Dipalmitoylphosphatidylcholine /phosphatidylglycerol Prevention and treatment of neonatal respiratory distress syndrome. 07/28/1988 Designated
1874 diphenylcyclopenone Treatment of chronic severe forms of alopecia areata (Alopecia Totalis AT/Alopecia Universalis AU) 06/13/2003 Designated
1875 Diphenylcyclopropenone gel Treatment of malignant melanoma stage IIB to IV 04/15/2015 Designated
1876 dipraglurant Treatment of levodopa-induced dyskinesias 12/29/2015 Designated
1877 Disaccharide tripeptide glycerol dipalmitoyl Treatment of pulmonary and hepatic metastases in patients with colorectal adenocarcinoma. 03/01/1990 Designated
1878 Disodium clodronate Treatment of hypercalcemia of malignancy. 06/16/1993 Designated
1879 Disodium clodronate tetrahydrate Treatment of increased bone resorption due to malignancy. 03/05/1990 Designated
1880 Disodium silibinin dihemisuccinate Treatment of hepatic intoxication by Amanita phalloides (mushroom poisoning). 07/10/1986 Designated/Withdrawn
1881 disufenton sodium Treatment of glioblastoma multiforme 08/22/2016 Designated
1882 disulfide-stabilized single-chain variable region fragment of the anti-EGFR wild type/EGFRvIII dual specificity monoclonal antibody with variable fragments fused to a truncated version of the Pseudomonas exotoxin A, PE38, and KDEL Treatment of glioma. 09/19/2016 Designated
1883 DL-3-n-butylphthalide Treatment of amyotrophic lateral sclerosis (ALS) 02/28/2018 Designated
1884 DNA plasmid encoding the acetylcholine receptor Treatment of myasthenia gravis. 04/18/2011 Designated/Withdrawn
1885 DNA plasmid expressing diphtheria toxin triggered by the presence of oncofetal gen H19 Treatment of ovarian cancer 08/20/2009 Designated
1886 DNA plasmid vector (pCK-HGFX7) expressing human hepatocyte growth factor Treatment of amyotrophic lateral sclerosis 02/06/2014 Designated
1887 DNA Plasmid Vector encoding IL-12 (pUMVC3-hIL-12-NGVL331) Treatment of Stage IIB, IIc, III, and IV melanoma (which includes use in combination with pembrolizumab) 06/06/2017 Designated
1888 DNA plasmid vector expressing eIF5Ak50 Treatment of multiple myeloma. 12/13/2010 Designated
1889 DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the nastive eIF5A mRNA, and PEI (polyethyleneimine) Treatment of diffuse large B cell lymphoma 07/24/2012 Designated
1890 DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the native eIF5A mRNA, and PEI (polyethyleneimine) Treatment of mantle cell lymphoma 07/24/2012 Designated
1891 DNA plasmid vector expressing human IL-12 gene Treatment of ovarian cancer. 04/04/2005 Designated
1892 DNA, (Cm-Gm-Gm-Gm-G-T-G-T-G-G-G-T-T-C-G-T-C-G-T-T-A-G-C-T-T-G-A-T-T-T-G-G-C-A-G-C-Um-Gm-Cm-Cm-(3'¿3')-dT), 5'-ester with 5-(phosphoonoxy) pentyl amino carbonyl-oxy-1, 2-ethanediyl, sodium salt Treatment of Osteogenesis Imperfecta 08/19/2019 Designated
1893 DNA-lipid complex (DMRIE/DOPE)/plasmid vector (VCL-1102, Vical) expressing human interleukin-2 Treatment of renal cell carcinoma. 04/28/2000 Designated
1894 DNP-Modified autologous tumor vaccine Adjuvant therapy for the treatment of ovarian cancer 09/21/2000 Designated
1895 docarpamine Treatment of ascites due to all etiologies except cancer 04/14/2020 Designated
1896 docetaxel encapsulated in an albumin-stabilized liposome Treatment of small cell lung cancer (SCLC) 09/12/2018 Designated
1897 docosahexaenoic acid Treatment of short bowel syndrome 06/01/2015 Designated
1898 docosahexaenoic acid Treatment of sickle cell disease 04/27/2015 Designated
1899 docosahexaenoic acid, DHA Treatment of primary sclerosing cholangitis 12/17/2014 Designated
1900 docosahexanoic acid-paclitaxel Treatment of hormone-refractory prostate cancer. 03/05/2001 Designated/Withdrawn
1901 dodecafluoropentane emulsion Treatment of sickle cell disease 02/11/2016 Designated
1902 dodecafluoropentane emulsion (DDFPe) Radiosensitizer to be used during radiation treatment of glioblastoma multiforme (GBM). 12/02/2015 Designated
1903 domperidone Treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions following the use of cabergoline or bromocriptine in mothers who wish to initiate or return to breastfeeding 09/02/2011 Designated
1904 dopamine hydrochloride Prevention of intraventricular hemorrhage in hypotensive premature neonates 10/24/2017 Designated
1905 doranidazole radiosensitizer to be used during radiation treatment of pancreatic cancer 11/30/2018 Designated
1906 Doripenem Treatment of bronchopulmonary infection in patients with cystic fibrosis who are colonized with Pseudomonas aeruginosa or Burkholderia cepacia. 07/16/2004 Designated
1907 dornase alfa Treatment of sarcoidosis 06/04/2019 Designated
1908 Dornase alfa To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis. 01/16/1991 Designated/Approved
1909 double stranded oligomer AD00370 RNA interference-based liver targeted therapeutic Treatment of Alpha-1 Antitrypsin deficiency 06/09/2015 Designated/Withdrawn
1910 double stranded oligomer ADS-001 RNA interference-based liver targeted therapeutic Treatment of alpha-1 antitrypsin deficiency 02/14/2018 Designated
1911 Double stranded oligomer ARO-APOC3 RNA interference-based liver targeted therapeutic Treatment of Familial Chylomicronemia Syndrome 06/20/2019 Designated
1912 Double stranded oligomer RNA interference-based liver targeted therapeutic directed against the ANGPTL3 gene Treatment of homozygous familial hypercholesterolemia 07/15/2019 Designated
1913 double stranded RNA which targets the mutated KRAS oncogene Treatment of pancreatic cancer 01/26/2015 Designated
1914 Double-stranded DNA plasmid carrying the gene for the diphtheria toxin A (DT-A) chain Treatment of pancreatic cancer 08/06/2010 Designated
1915 Dovitinib Treatment of multiple myeloma 10/03/2006 Designated/Withdrawn
1916 dovitinib Treatment of adenoid cystic carcinoma 09/26/2013 Designated
1917 doxofylline Treatment of bronchiectasis 02/14/2014 Designated
1918 doxorubicin Treatment of cutaneous T-cell lymphoma 04/06/2015 Designated
1919 doxorubicin Treatment of hepatocellular carcinoma. 08/25/2009 Designated
1920 doxorubicin HCL liposome injection Treatment of multiple myeloma 12/29/2004 Designated/Approved
1921 Doxorubicin HCl with pluronic L-61 and pluronic F-127 Treatment of esophageal carcinoma 10/07/2005 Designated
1922 Doxorubicin liposome Treatment of ovarian cancer. 11/04/1998 Designated/Approved
1923 doxorubicin nanoparticles Treatment of hepatocellular carcinoma 03/14/2005 Designated/Withdrawn
1924 doxorubicin with pluronics F-127 and L-61 Treatment of gastric cancer 02/20/2008 Designated
1925 DPX-Survivac Treatment of ovarian cancer. 07/14/2015 Designated
1926 Dronabinol For the stimulation of appetite and prevention of weight loss in patients with a confirmed diagnosis of AIDS. 01/15/1991 Designated/Approved
1927 droxidopa Treatment of neurogenic symptomatic orthostatic hypotension in patients with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy. 01/17/2007 Designated/Approved
1928 drug component, inhaled nitric oxide, of the inhaled nitric oxice/INOpulse® Device combination product Treatment of idiopathic pulmonary fibrosis 09/10/2019 Designated
1929 dry extract from Betulae Cortex (birch bark) Treatment of epidermolysis bullosa 08/07/2014 Designated
1930 Dual antibody including HBV-Ab 17, libivirumab, and HBV-Ab 19, exbivirumab For the prevention of hepatitis B virus (HBV) reinfection in patients who have received a liver transplantation 07/15/2003 Designated/Withdrawn
1931 dual E-selectin and C-X-C chemokine receptor Type 4 (CXCR4) antagonist that targets both E-selectin and CXCR4 Treatment of osteosarcoma 01/27/2020 Designated
1932 dual signaling protein fusing cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) to the Fas-ligand (FasL) Treatment of diffuse large B-cell lymphoma 12/13/2017 Designated
1933 dupilumab Treatment of eosinophilic esophagitis 09/05/2017 Designated
1934 dupilumab Treatment of bullous pemphigoid 08/21/2019 Designated
1935 Duramycin Treatment of cystic fibrosis. 12/11/1997 Designated
1936 durvalumab Treatment of small cell lung cancer 07/10/2019 Designated/Approved
1937 durvalumab Treatment of hepatocellular carcinoma 01/15/2020 Designated
1938 dusquetide Treatment of macrophage activation syndrome 08/10/2016 Designated
1939 duvelisib Treatment of T-Cell Lymphoma 10/02/2019 Designated
1940 duvelisib Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma 04/15/2013 Designated/Approved
1941 duvelisib Treatment of follicular lymphoma 08/01/2013 Designated/Approved
1942 duvoglustat hydrochloride Treatment of Pompe disease 06/18/2007 Designated/Withdrawn
1943 Dynamine Treatment of hereditary motor and sensory neuropathy type I (Charcot-Marie-Tooth disease). 10/16/1991 Designated
1944 Dynamine Treatment of Lambert Eaton myasthenic syndrome. 02/05/1990 Designated
1945 E-selectin antagonist Treatment of acute myeloid leukemia (AML) 05/13/2015 Designated
1946 ecallantide Treatment of angioedema 02/04/2003 Designated/Approved
1947 ecallantide Treatment of angioedema 02/04/2003 Designated/Approved
1948 echinomycin Treatment of graft-versus-host disease (GVHD) 01/05/2017 Designated
1949 echinomycin Treatment of acute myeloid leukemia. 05/21/2015 Designated
1950 echothiophate iodide Treatment of Stargardt's disease 06/02/2014 Designated
1951 ecopipam hydrochloride Treatment of pediatric patients with Tourette's syndrome. 09/29/2010 Designated
1952 ecopipam hydrochloride Symptomatic treatment of self injurious behaviors in patients with Lesch-Nyhan disease. 07/21/2009 Designated
1953 eculizumab Treatment of Shiga-Toxin producing escherichia coli hemolytic uremic syndrome 10/18/2011 Designated
1954 eculizumab Treatment of atypical hemolytic uremic syndrome 04/29/2009 Designated/Approved
1955 eculizumab Treatment of Myasthenia Gravis 06/12/2014 Designated/Approved
1956 eculizumab Treatment of idiopathic membranous glomerular nephropathy 03/05/2001 Designated
1957 eculizumab Treatment of neuromyelitis optica 06/24/2013 Designated/Approved
1958 eculizumab Treatment of paroxysmal nocturnal hemoglobinuria 08/20/2003 Designated/Approved
1959 eculizumab Prevention of delayed graft function after renal transplantation 01/10/2014 Designated
1960 Eculizumab Treatment of dermatomyositis 09/21/2000 Designated
1961 edaravone Treatment of amyotrophic lateral sclerosis 05/12/2015 Designated/Approved
1962 edaravone Treatment of amyotrophic lateral sclerosis 03/12/2015 Designated
1963 Edasalonexent Treatment of Duchenne muscular dystrophy 11/17/2014 Designated
1964 Edotreotide Treatment of somatostatin receptor-positive neuroendocrine gastroenteropancreatic tumors 07/28/2005 Designated
1965 efaproxiral Adjunct to whole brain radiation therapy for the treatment of brain metastases in patients with breast cancer 07/28/2004 Designated
1966 Efdispo Treatment of Ewings Sarcoma 01/15/2013 Designated
1967 efgartigimod Treatment of myasthenia gravis 09/20/2017 Designated
1968 efgartigimod Treatment of Primary Immune Thrombocytopenia (ITP) 02/01/2019 Designated
1969 Eflornithine Treatment of anaplastic glioma 09/29/2006 Designated
1970 eflornithine Treatment of Familial Adenomatous Polyposis 02/04/2011 Designated
1971 eflornithine Treatment of neuroblastoma 11/23/2010 Designated
1972 eflornithine Treatment of pancreatic cancer. 12/14/2016 Designated
1973 eflornithine Treatment of neuroblastoma 11/22/2017 Designated
1974 Eflornithine HCl Treatment of Pneumocystis carinii pneumonia in AIDS patients. 04/18/1986 Designated/Withdrawn
1975 eflornithine + sulindac Treatment of pancreatic cancer 01/08/2018 Designated
1976 eflornithine HCL Treatment of gastric cancer 04/07/2015 Designated
1977 Eflornithine HCl Treatment of Trypanosoma brucei gambiense infection (sleeping sickness). 04/23/1986 Designated/Approved
1978 eflornithine plus sulindac Treatment of familial adenomatous polyposis 01/22/2013 Designated
1979 efmitermant alfa Treatment of Charcot-Marie-Tooth disease 02/28/2019 Designated/Withdrawn
1980 eicosapentaenoic acid Treatment of familial adenomatous polyposis 03/08/2011 Designated
1981 elacytarabine Treatment of acute myeloid leukemia (AML) 06/18/2008 Designated
1982 elafibranor Treatment of Primary Biliary Cholangitis 07/25/2019 Designated
1983 elamipretide Treatment of Barth syndrome 03/22/2018 Designated
1984 elamipretide Treatment of Leber’s Hereditary Optic Neuropathy 04/02/2018 Designated
1985 elamipretide Treatment of primary mitochondrial myopathy 09/05/2017 Designated
1986 elapegademase-lvlr Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency. 03/19/2015 Designated/Approved
1987 Elcatonin Intrathecal treatment of intractable pain. 09/25/1995 Designated
1988 electrokinetically altered saline solution with an elevated dissolved oxygen concentration Treatment of amyotrophic lateral sclerosis (ALS) 07/10/2017 Designated
1989 Elesclomol Treatment of metastatic melanoma in combination with paclitaxel 12/18/2007 Designated
1990 elexacaftor/tezacaftor/ivacaftor Treatment of Cystic Fibrosis 08/29/2018 Designated/Approved
1991 elezanumab Treatment of acute spinal cord injury 03/17/2020 Designated
1992 eliglustat Treatment of Type I Gaucher disease 09/17/2008 Designated/Approved
1993 elosulfase alfa Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome) 05/15/2009 Designated/Approved
1994 elotuzumab Treatment of multiple myeloma 09/01/2011 Designated/Approved
1995 elotuzumab Treatment of multiple myeloma 09/01/2011 Designated/Approved
1996 eltoprazine HCl Treatment of levodopa-induced dyskinesia associated with Parkinson's disease. 02/08/2016 Designated
1997 eltrombopag Treatment of aplastic anemia 11/08/2013 Designated/Approved
1998 eltrombopag Treatment of aplastic anemia 11/08/2013 Designated/Approved
1999 eltrombopag Treatment of idiopathic thrombocytopenia purpura 05/05/2008 Designated/Approved
2000 Emapalumab-lzsg Treatment of hemophagocytic lymphohistiocytosis 03/26/2010 Designated/Approved
2001 emeramide Treatment of mercury toxicity 04/06/2012 Designated
2002 emicizumab-kxwh Treatment of hemophilia A 01/10/2014 Designated/Approved
2003 emicizumab-kxwh Treatment of hemophilia A 01/10/2014 Designated/Approved
2004 emixustat Treatment of Stargardt disease (STGD) 01/04/2017 Designated
2005 emodepside Treatment of onchocerhiasis ("river blindness") caused by the filarial nematode onchocerca volvulus 09/13/2016 Designated
2006 emricasan Treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end stage liver disease 11/20/2013 Designated
2007 emtricitabine and tenofovir alafenamide combination Treatment of HIV-1 infection in pediatric patients under 12 years of age 06/06/2017 Designated/Approved
2008 Enadoline hydrochloride Treatment of severe head injury. 01/28/1997 Designated
2009 enalapril maleate (powder for oral solution) Treatment of hypertension in pediatric patients 01/30/2013 Designated/Withdrawn
2010 enasidenib Treatment of acute myelogenous leukemia 06/12/2014 Designated/Approved
2011 Encapsulated porcine islet preparation Treatment of type I diabetic patients who are already on immunosuppression. 07/05/1995 Designated
2012 encapsulated rapamycin Treatment of familial adenomatous polyposis 03/15/2019 Designated
2013 encapsulated spores from fecal microbiota Treatment of recurrent Clostridium difficile infection (CDI) 08/19/2015 Designated
2014 enchochleate amphotericin B Treatment of visceral leishmaniasis 01/10/2014 Designated
2015 encochleated amikacin Treatment of non-tuberculous mycobacteria (NTM) infections 03/03/2016 Designated
2016 Encochleated oral Amphotericin B suspension Treatment of cryptococcosis 10/03/2019 Designated
2017 encorafenib Treatment of Stage IIB-IV melanoma positive for BRAF mutation 11/19/2013 Designated
2018 encorafenib + binimetinib Treatment of Stage IIB-IV melanoma positive for the BRAF mutation. 11/19/2013 Designated/Approved
2019 encorafenib + binimetinib Treatment of Stage IIB-IV melanoma positive for the BRAF mutation. 11/19/2013 Designated/Approved
2020 Endothelin receptor B antagonist Treatment of malignant melanoma Stages IIB to IV. 01/21/2016 Designated
2021 enfumafungin derivative B-(1,3)-D-glucan synthestis inhibitor Treatment of invasive Candida infections, including candidemia 05/10/2016 Designated
2022 EnGeneIC delivery vehicles loaded with doxorubicin and targeted to tumor with sequences from Vectibix and mouse monoclonal antibody Treatment glioblastoma multiforme 02/14/2017 Designated
2023 Engineered variant of recombinant human fibroblast growth factor 19 Treatment of primary biliary cirrhosis 02/06/2014 Designated
2024 eniluracil Treatment of hepatocellular carcinoma. 12/15/2005 Designated
2025 enisoprost 1. For use with cyclosporine in organ transplant recipients to reduce acute transplant rejection 2. For use in organ transplant patients to diminish the nephrotoxicity induced by cyclosporine. 10/20/1989 Designated/Withdrawn
2026 ensituximab Treatment of pancreatic cancer. 10/21/2010 Designated
2027 entolimod Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster 11/23/2010 Designated
2028 entospletinib Prevention of chronic graft-versus-host disease 08/10/2017 Designated
2029 entospletinib Treatment of acute myeloid leukemia 06/15/2017 Designated
2030 entospletinib Treatment of chronic lymphocytic leukemia 04/14/2014 Designated
2031 entrectinib Treatment of NTRK fusion-positive solid tumors 07/05/2017 Designated/Approved
2032 entrectinib Treatment of TrkA-positive, TrkB-positive, TrkC-positive ROS1-positive or ALK-positive non-small cell lung cancer 02/03/2015 Designated/Approved
2033 entrectinib Treatment of neuroblastoma 12/22/2014 Designated/Withdrawn
2034 Envafolimab Treatment of biliary tract cancer 01/16/2020 Designated
2035 enzastaurin Treatment of diffuse large B-cell lymphoma 03/04/2009 Designated
2036 Enzastaurin Treatment of glioblastoma multiforme 09/19/2005 Designated
2037 enzyme transport vehicle specific for the transferrin receptor fused to iduronate 2-sulfatase Treatment of mucopolysaccharidosis type II 02/19/2019 Designated
2038 epacadostat Treatment of stage IIB-IV melanoma. 02/11/2016 Designated
2039 epalrestat Treatment of phosphomannomutase-2 deficiency, a congenital disorder of glycosylation 03/26/2020 Designated
2040 Epidermal growth factor (human) For acceleration of corneal epithelial regeneration and the healing of stromal tissue in the condition of non-healing corneal defects. 10/05/1987 Designated
2041 Epidermal growth factor (human) For promotion of cutaneous wound healing in extreme burn treatment protocols. 03/06/1985 Designated/Withdrawn
2042 Epirubicin Treatment of breast cancer. 09/14/1999 Designated/Approved
2043 epirubicin-conjugated polymer micelles Treatment of soft tissue sarcoma 07/13/2017 Designated
2044 Episcleral Topotecan Treatment of retinoblastoma 07/24/2019 Designated
2045 Epitalon Treatment of retinitis pigmentosa 09/02/2010 Designated/Withdrawn
2046 Epoetin alfa Treatment of anemia associated with HIV infection or HIV treatment. 07/01/1991 Designated/Approved
2047 Epoetin alfa Treatment of myelodysplastic syndrome. 12/20/1993 Designated
2048 Epoetin alfa Treatment of anemia associated with end stage renal disease. 04/10/1986 Designated/Approved
2049 Epoetin alpha Treatment of anemia of prematurity in preterm infants. 07/21/1988 Designated/Withdrawn
2050 Epoetin alpha Treatment of anemia associated with end stage renal disease. 08/27/1987 Designated
2051 Epoetin alpha Treatment of HIV associated anemia related to HIV infection or HIV treatment. 03/07/1989 Designated
2052 Epoetin beta Treatment of anemia associated with end stage renal disease. 10/22/1987 Designated
2053 epoprostenol Treatment of Frostbite 04/20/2020 Designated
2054 Epoprostenol Treatment of primary pulmonary hypertension. 09/25/1985 Designated/Approved
2055 epoprostenol Treatment of secondary pulmonary hypertension due to intrinsic precapillary pulmonary vascular disease. 03/22/1999 Designated/Approved
2056 Epoprostenol Replacement of heparin in patients requiring hemodialysis and who are at risk of hemmorrage 03/29/1984 Designated/Withdrawn
2057 Epoprostenol Replacement of heparin in patients requiring hemodialysis and who are at increased risk of hemorrhage. 10/29/1984 Designated/Withdrawn
2058 epratuzumab Treatment of acute lymphoblastic leukemia 09/30/2008 Designated/Withdrawn
2059 epratuzumab Treatment of non-Hodgkin's lymphoma 07/13/1998 Designated/Withdrawn
2060 eprodisate Treatment of secondary amyloidosis 04/06/1999 Designated
2061 Epstein Barr Virus specific cytotoxic T lymphocytes Prevention and treatment of EBV-post transplant lymphoproliferative disease after hematopoietic stem cell transplant or solid organ transplant. 12/27/2006 Designated/Withdrawn
2062 Epstein-Barr virus-specific autologous cytotoxic T lymphocytes Treatment of Epstein-Barr virus positive head and neck cancers (which includes nasopharyngeal carcinoma) 06/12/2014 Designated
2063 eptifibatide and iloprost Treatment of purpura fulminans 04/20/2012 Designated
2064 erdosteine Treatment of bronchiectasis. 12/20/2013 Designated
2065 eribulin mesylate Treatment of soft tissue sarcoma 05/14/2012 Designated/Approved
2066 Erlotinib Hydrochloride Treatment of malignant gliomas 07/18/2003 Designated
2067 Erwinia L-asparaginase Treatment of acute lymphocytic leukemia. 07/30/1986 Designated/Approved
2068 Erwinia L-asparaginase For use as an alternative to E. coli asparaginase in those situations where repeat courses of asparaginase therapy for acute lymphoblastic leukemia are required or where allergic reactions force the discontinuance of the E. coli preparation. 01/25/1985 Designated/Withdrawn
2069 Erythropoietin (human, recombinant) Treatment of anemia associated with end stage renal disease. 11/19/1987 Designated/Withdrawn
2070 Erythropoietin (recombinant human) Treatment of anemia associated with end stage renal disease. 08/19/1987 Designated
2071 esomeprazole Treatment of Eosinophilic Esophagitis 05/15/2019 Designated
2072 estetrol Treatment of neonatal hypoxic ischemic encephalopathy 03/28/2019 Designated
2073 estradiol Gel Estrogen replacement therapy in females with Turner syndrome 10/31/2006 Designated
2074 Etanercept Treatment of Wegener's granulomatosis. 04/06/1999 Designated/Withdrawn
2075 etanercept Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. 10/27/1998 Designated/Approved
2076 etaracizumab For the treatment of of stage IIb, stage IIc, stage III and stage IV melanoma 04/14/2004 Designated/Withdrawn
2077 etarfolatide For the identification of ovarian carcinomas 02/16/2000 Designated
2078 etelcalcetide Treatment of pediatric hyperparathyroidism 05/31/2017 Designated
2079 eteplirsen Treatment of Duchenne Muscular Dystrophy. 10/23/2007 Designated/Approved
2080 Ethanol gel Treatment of congenital venous malformations 03/29/2006 Designated/Withdrawn
2081 Ethanol gel Treatment of congenital lymphatic malformations 03/13/2006 Designated/Withdrawn
2082 ethanolamine Prophylactic use in pediatric patients (age 0 through 16 years) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding 01/17/2014 Designated
2083 Ethanolamine oleate Treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. 03/22/1984 Designated/Approved
2084 Ethinyl Estradiol, USP Treatment of Turner's syndrome. 06/22/1988 Designated/Withdrawn
2085 ethiodized oil injection Management of patients with known hepatocellular carcinoma (HCC) 09/26/2013 Designated/Approved
2086 Ethiofos Use as a chemoprotective agent for cisplatin and cyclophosphamide in the treatment of ovarian cancer. 08/01/1989 Designated/Withdrawn
2087 Ethyl 4-(3,4-dimethoxyphenyl)-6,7-dimethoxy-2-(1,2,4-triazol-1-ylmethyl)quinoline-3-carboxylate Treatment of Crohn's disease. 05/13/1998 Designated/Withdrawn
2088 Ethyl eicosapentaenoate Treatment of Huntington's disease. 04/06/2000 Designated
2089 Etidronate disodium Prevention of degenerative metabolic bone disease occurring in patients who require long term (6 months or greater) total parenteral nutrition. 05/02/1991 Designated/Withdrawn
2090 Etidronate disodium Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration. 03/21/1986 Designated/Approved
2091 Etidronate disodium Treatment of degenerative metabolic bone disease occurring in patients who require long term (6 months or greater) total parenteral nutrition. 05/02/1991 Designated/Withdrawn
2092 Etiocholanedione Treatment of Prader-Willi syndrome. 05/07/1996 Designated
2093 Etiocholanedione Treatment of aplastic anemia. 11/03/1995 Designated
2094 etirinotecan pegol Treatment of ovarian cancer. 04/18/2011 Designated
2095 etoposide toniribate Treatment of biliary tract cancer 02/11/2019 Designated
2096 etrolizumab Treatment of pediatric patients with ulcerative colitis 08/22/2016 Designated
2097 etrolizumab Treatment of pediatric Crohn's disease. 07/13/2017 Designated
2098 Eubacterial Spores, Purified Suspension, Encapsulated Treatment of pediatric ulcerative colitis 11/27/2017 Designated
2099 everolimus Treatment of neuroendocrine tumors 02/14/2008 Designated/Approved
2100 everolimus Treatment of gastric cancer 05/24/2011 Designated/Withdrawn
2101 everolimus Treatment of neuroendocrine tumors 02/14/2008 Designated/Approved
2102 everolimus Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM) 06/08/2009 Designated/Approved
2103 everolimus Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM) 06/08/2009 Designated/Approved
2104 everolimus Treatment of diffuse large B-cell lymphoma 06/02/2014 Designated/Withdrawn
2105 everolimus Treatment of Waldenstrom macroglobulinemia (also known as lymphoplasmacytic lymphoma) 09/16/2010 Designated/Withdrawn
2106 everolimus Treatment of hepatocellular carcinoma 07/23/2012 Designated/Withdrawn
2107 everolimus Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM) 06/08/2009 Designated/Approved
2108 everolimus ointment Topical treatment of Tuberous Sclerosis Complex-related skin lesions 09/10/2015 Designated
2109 evinacumab Treat of homozygous familial hypercholesterolemia. 02/08/2016 Designated
2110 evolocumab Treatment of homozygous familial hypercholesterolemia 09/12/2013 Designated/Approved
2111 ex vivo cultured adult human mesenchymal stem cells Treatment of acute graft versus host disease 12/14/2005 Designated
2112 ex vivo cultured human mesenchymal stromal cells Prevention of graft rejection following solid organ transplantation 05/08/2014 Designated
2113 ex vivo expanded autologous human corneal epithelial cells containing stem cells Treatment of limbal stem cell deficiency 04/26/2018 Designated
2114 ex-vivo cultered adult human mesenchymal stem cells Treatment of Type 1 diabetes patients with residual beta cell function 04/30/2010 Designated
2115 ex-vivo expanded autologous bone marrow-derived mesenchymal stem cells Treatment of Amyotrophic Lateral Sclerosis 12/20/2010 Designated
2116 ex-vivo expanded placental adherent stromal cells Treatment of graft failure and incomplete hematopoietic recovery, following hematopoietic cell transplantation (HCT) 09/24/2018 Designated
2117 ex-vivo expanded placental adherent stromal cells Treatment of acute radiation syndrome 09/20/2017 Designated
2118 ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the human COL7A1 gene. Treatment of dystrophic Epidermolysis Bullosa 05/24/2017 Designated
2119 Exemestane Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 09/19/1991 Designated/Approved
2120 exenatide Treatment of idiopathic intracranial hypertension 05/16/2017 Designated
2121 Exendin 9-39 (Competitive antagonist of glucagon-like peptide-1) Treatment of hyperinsulinemic hypoglycemia 12/08/2016 Designated
2122 exendin-(9-39) Treatment of congential hyperinsulinenic hypoglycemia and other causes of hyperinsulinemic hypoglycemia in adults and children 06/01/2011 Designated
2123 Exisulind For the suppression and control of colonic adenomatous polyps in the inherited disease adenomatous polyposis coli. 02/14/1994 Designated
2124 Exon 44 specific phosphorothioate oligonucleotide Treatment of Duchenne Muscular Dystrophy in patients who have a mutation correctable by skipping of exon 44of the dystrophin gene. 11/05/2009 Designated
2125 Exon 45 specific phosphorothioate oligonucleotide Treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 45 01/23/2013 Designated
2126 Exon 46 specific phosphorothioate oligonucleotide Treatment of Duchenne muscular dystrophy 11/18/2005 Designated/Withdrawn
2127 Exon 51 specific phosphorothioate oligonucleotide Treatment of Duchenne Muscular Dystrophy. 08/25/2009 Designated
2128 Exon 52 specific phosphorothiate oligonucleotide Treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 52 01/23/2013 Designated
2129 Exon 53 specific antisense morpholino oligonucleotide. Treatment of Duchenne Muscular Dystrophy 01/12/2017 Designated
2130 exon 53 specific phosphorothioate oligonucleotide treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 53 01/23/2013 Designated
2131 Exon 55 specific phosphorothioate oligonucleotide Treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 55 01/23/2013 Designated
2132 expanded allogeneic human dermal fibroblasts in hypothermosol(r)-FRS Treatment of Dystrophic Epidermolysis Bullosa. 08/20/2009 Designated
2133 expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue Treatment of fistulizing Crohn's disease 10/18/2017 Designated
2134 expanded human allogeneic neural retinal progenitor cells extracted from neural retina Treatment of retinitis pigmentosa 08/22/2013 Designated
2135 expanded human autologous chondrocytes in a biopolymer (sodium alginate, gellan gum) matrix Treatment of microtia (including anotia) 03/25/2019 Designated
2136 extracellular domain of Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 fused to the Fc region of human IgG1 Treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 deficiency (generalized arterial calcification of infancy and autosomal recessive hypophosphatemic rickets type 2) 06/11/2018 Designated
2137 Extract of sea cucumber, sea sponge, shark fin, sea urchin, and sargassum grass Treatment of multiple myeloma 05/14/2012 Designated
2138 extract of sorghum bicolor extract Treatment of sickle cell disease 11/19/2012 Designated
2139 Extracts of herbs Scutellaria baicalensis Geori, Glycyrrhiza uralensis Fisch, Paeonia lactiflora Pall, and Ziziphus jujuba Mill Treatment of pancreatic cancer 02/11/2019 Designated
2140 ezatiostat hydrochloride Treatment of myelodysplastic syndrome 01/09/2013 Designated
2141 ezogabine Treatment of KCNQ2 epileptic encephalopathy 06/21/2018 Designated
2142 faceted gold nanocrystals Treatment of Amyotrophic Lateral Sclerosis 05/08/2019 Designated
2143 Facilitated DNA Plasmid Vaccine Treatment of cutaneous T cell lymphoma. 03/08/1995 Designated
2144 factor XIII concentrate (human) Treatment of congenital factor XIII deficiency 01/16/1985 Designated/Approved
2145 factor XIII concentrate (human) Treatment of congenital factor XIII deficiency 01/16/1985 Designated/Approved
2146 Factor XIII A2 homodimer, recombinant DNA origin Treatment of congenital FXIII deficiency 05/21/2003 Designated
2147 Factor XIII, recombinant Treatment of congenital factor XIII deficiency. 04/22/1993 Designated/Withdrawn
2148 Fampridine Treatment of chronic, incomplete spinal cord injury. 06/02/1997 Designated
2149 Fancalen (lentiviral vector containing the Fanconi anemia-A (FANCA) gene Treatment of Fanconi anemia type A patients. 05/02/2016 Designated
2150 farletuzumab Treatment of ovarian cancer 06/16/2006 Designated
2151 fast skeletal muscle troponin activator Treatment of spinal muscular atrophy 05/11/2017 Designated
2152 fasudil Treatment of subarachnoid hemorrhage 09/05/2019 Designated
2153 Fasudil Treatment of Amyotrophic Lateral Sclerosis 01/15/2020 Designated
2154 Fc fusion protein of a human inducible T cell costimulator ligand variant immunoglobulin domain designed to inhibit simultaneously the CD28 and ICOS inflammation pathways Treatment of Acute Graft versus Host Disease 03/16/2020 Designated
2155 Fc fusion protein of a human inducible T cell costimulator ligand variant immunoglobulin domain designed to inhibit simultaneously the CD28 and ICOS inflammation pathways Prevention of acute graft versus host disease 03/16/2020 Designated
2156 fecal microbiota Prevention of recurrent Clostridium difficile infection (CDI) in individuals with recurrent Clostridium difficile infection 03/10/2014 Designated
2157 Fedratinib Treatment of polycythemia vera 03/21/2013 Designated
2158 Fedratinib Treatment of secondary and primary myelofibrosis 05/18/2009 Designated/Approved
2159 Felbamate Treatment of Lennox-Gastaut syndrome. 01/24/1989 Designated/Approved
2160 fenfluramine Treatment of Lennox-Gastaut syndrome 06/19/2017 Designated
2161 fenfluramine HCI For the Treatment of Dravet Syndrome 12/20/2013 Designated
2162 Fenobam hydrochloride Treatment of fragile X syndrome 11/20/2006 Designated
2163 fenretinide Treatment of Ewing's sarcoma family of tumors. 02/01/2007 Designated/Withdrawn
2164 fenretinide Treatment of cutaneous T-cell lymphoma 12/19/2017 Designated
2165 fenretinide Treatment of peripheral T-cell lymphoma (including follicular T-cell lymphoma) 12/22/2017 Designated
2166 fenretinide Treatment of cutaneous T-cell lymphoma 09/04/2013 Designated
2167 fenretinide Treatment of peripheral T-cell lymphoma 09/04/2013 Designated
2168 Fenretinide Treatment of neuroblastoma 10/05/2005 Designated
2169 Fenretinide Treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients 04/07/2010 Designated
2170 ferric hexacyanoferrate (II) "Prussian Blue" Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium 06/26/2003 Designated
2171 ferumoxytol For use in magnetic resonance imaging in brain metastases 10/07/2011 Designated
2172 ferumoxytol For use in MR imaging for the mangement of brain tumors 04/29/2011 Designated
2173 ferumoxytol For use in magnetic resonance imaging to assess, and monitor treatment of solid tumor malignancies previously diagnosed in pediatric patients (age 16 years and younger) 04/06/2012 Designated
2174 fexinidazole Treatment of human African trypanosomiasis (HAT) or sleeping sickness 04/04/2016 Designated
2175 fialuridine Adjunctive treatment of chronic active hepatitis B. 07/24/1992 Designated
2176 Fibrin-based agent containing a N-terminally modified parathyroid hormone fragment TGplPTH1-34 Treatment of solitary (unicameral) bone cysts 02/01/2007 Designated
2177 Fibrinogen (human) For the control of bleeding and prophylactic treatment of patients deficient in fibrinogen. 08/23/1995 Designated
2178 fibrinogen-depleted human platelet lysate Treatment of ocular graft-versus-host disease 02/24/2020 Designated
2179 Fibromun Treatment of Soft Tissue Sarcoma 12/18/2018 Designated
2180 Fibronectin (human plasma derived) Treatment of non-healing corneal ulcers or epithelial defects which have been unresponsive to conventional therapy and the underlying cause has been eliminated. 09/05/1988 Designated
2181 Fibronectin (plasma derived) Treatment of non-healing corneal ulcers or epithelial defects which are unresponsive to conventional therapy and for which any infectious cause of the defect has been eliminated. 12/05/1988 Designated/Withdrawn
2182 Fibronectin Peptide Prevention of burn injury progression of acute, deep dermal burns in hospitalized patients. 06/29/2011 Designated
2183 fidaxomicin Treatment of pediatric Clostridium difficile infection 12/13/2010 Designated/Approved
2184 filanesib Treatment of multiple myeloma. 05/06/2014 Designated
2185 filgotinib maleate Treatment of pediatric ulcerative colitis (UC) 10/05/2017 Designated
2186 filgotinib maleate Treatment of pediatric Crohn's disease 07/18/2017 Designated
2187 Filgrastim Treatment of myelodysplastic syndrome 08/30/1990 Designated/Withdrawn
2188 filgrastim Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident 11/20/2013 Designated/Approved
2189 Filgrastim Treatment of neutropenia associated with bone marrow transplants. 10/01/1990 Designated/Approved
2190 Filgrastim Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia. 11/07/1996 Designated/Approved
2191 Filgrastim Treatment of patients with AIDS who, in addition, are afflicted with cytomegalovirus retinitis and are being treated with ganciclovir 09/03/1991 Designated/Withdrawn
2192 Filgrastim Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3). 11/07/1990 Designated/Approved
2193 Filgrastim For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy. 07/17/1995 Designated/Approved
2194 filgrastim Treatment of amyotrophic lateral sclerosis (ALS) 01/27/2015 Designated
2195 filociclovir Treatment of active cytomegalovirus infections 11/29/2010 Designated
2196 fimaporfin Treatment of cholangiocarcinoma 09/27/2017 Designated
2197 fingolimod Treatment of chronic inflammatory demyelinating polyneuropathy 04/30/2010 Designated
2198 firtecan pegol Treatment of neuroblastoma. 04/18/2011 Designated
2199 fish oil triglycerides Treatment of parenteral nutrition-associated liver disease 02/27/2008 Designated/Approved
2200 fixed combination of dimethyl fumarate and aspirin (162mg) Treatment of multiple sclerosis in patients who experience dimethyl fumarate flushing 09/27/2018 Designated
2201 fixed combination of diroximel fumarate and aspirin Treatment of patients with multiple sclerosis who experience the fumarate flush 04/06/2020 Designated
2202 Fixed combination of monomethyl fumarate and aspirin Treatment of patients with multiple sclerosis who experience the fumarate flush 04/06/2020 Designated
2203 fixed dose combination of methimazole and liothyronine Treatment of brain metastases in patients with primary lung cancer 03/06/2017 Designated
2204 fixed dose combination of modafinil and flecainide Treatment of narcolepsy 09/19/2016 Designated
2205 fixed dose combination of Pyronaridine and Benznidazole Treatment of Chagas Disease 05/11/2020 Designated
2206 fixed dose combination of pyronaridine tetraphosphate and artesunate Treatment of malaria 09/27/2018 Designated
2207 Fixed dose combination of relatlimab and nivolumab Treatment of gastric cancer (GC) and gastro-esophageal junction cancer (GEJ). 06/18/2018 Designated
2208 fixed-dose combination of celecoxib and ciprofloxacin. Treatment of amyotrophic lateral sclerosis 01/08/2020 Designated
2209 florbetaben F18 Diagnostic for the management of amyloid light chain (AL) amyloidosis 04/07/2020 Designated
2210 florilglutamic acid Diagnostic for the management of glioma 05/11/2016 Designated
2211 flotetuzumab Treatment of acute myeloid leukemia (AML) 12/22/2016 Designated
2212 Floxuridine, FUDR Intraperitoneal treatment of gastric cancer. 12/22/2004 Designated
2213 fluasterone Treatment of Cushing syndrome (including hyperglycemia, nonalcoholic fatty liver disease, and nonalcoholic steatosis) 03/28/2018 Designated
2214 flubendazole Treatment of onchocerciasis caused by Onchocerca volvulus 10/25/2013 Designated/Withdrawn
2215 flubendazole Treatment of lymphatic filariasis caused by nematodes of the family Filariodidea, in children and adults. 01/23/2014 Designated/Withdrawn
2216 flubrobenguane (18F) Diagnostic for the management of neuroendocrine tumors 06/04/2019 Designated
2217 fluciclovine (18F)(anti-1-amino-3-fluorocyclobutane-1-carboxylic acid, labelled with Fluorine-18) For the diagnosis of glioma 04/07/2015 Designated
2218 Fludarabine phosphate Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL. 04/18/1989 Designated/Approved
2219 Fludarabine phosphate Treatment and management of patients with non-Hodgkins lymphoma. 04/18/1989 Designated
2220 Fludarabine phosphate oral tablets Treatment of B-cell chronic lymphocytic leukemia 12/18/2007 Designated/Approved
2221 Flumecinol Treatment of hyperbilirubinemia in newborn infants unresponsive to phototherapy. 01/15/1985 Designated/Withdrawn
2222 flunarizine Treatment of alternating hemiplegia. 01/06/1986 Designated
2223 flunarizine Treatment of Alternating Hemiplegia 11/20/2018 Designated
2224 flunarizine Treatment of alternating hemiplegia 06/24/2013 Designated/Withdrawn
2225 flunarizine Treatment of hemiplegic migraine 07/20/2016 Designated
2226 Fluocinolone Treatment uveitis involving the posterior segment of the eye. 07/31/2000 Designated/Approved
2227 Fluorouracil For use in combination with interferon alpha-2a, recombinant, for the treatment of advanced colorectal carcinoma. 04/18/1990 Designated
2228 Fluorouracil For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma. 10/27/1989 Designated
2229 Fluorouracil For use in combination with leucovorin for therapy of metastatic adenocarcinoma of the colon and rectum. 02/06/1989 Designated/Withdrawn
2230 Fluorouracil Treatment of glioblastoma multiforme. 06/29/2000 Designated
2231 Fluoxetine Treatment of autism. 04/30/1999 Designated
2232 Fluoxetine Treatment of body dysmorphic disorder in children and adolescents 04/14/2004 Designated
2233 fluticasone propionate Treatment of pediatric and adult eosinophilic esophagitis 01/19/2011 Designated
2234 fluticasone propionate Treatment of eosinophilic esophagitis 12/29/2015 Designated
2235 folate binding protein peptide: Glu-Ile-Trp-Thr-His-Ser-Tyr-Lys-Val Treatment (including prevention of recurrence) of ovarian cancer 06/08/2016 Designated
2236 Folate Binding Protein Peptide: Glu-Ile-Trp-Thr-Phe-Ser-Thr-Lys-Val Treatment (including prevention of recurrence) of ovarian cancer 06/08/2016 Designated
2237 Follistatin291-IgG2 Fc fusion protein Treatment of facioscapulohumeral muscular dystrophy 07/03/2018 Designated/Withdrawn
2238 Follitropin alfa, recombinant For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. 12/21/1998 Designated/Approved
2239 Fomepizole Treatment of methanol or ethylene glycol poisoning. 12/22/1988 Designated/Approved
2240 Fomepizole Treatment of methanol or ethylene glycol poisoning. 12/22/1988 Designated/Approved
2241 fosbretabulin tromethamine Treatment of neuroendocrine tumors 12/29/2015 Designated
2242 fosbretabulin tromethamine Treatment of glioma 06/08/2016 Designated
2243 fosfomycin/tobramycin Treatment of pulmonary infections associated with cystic fibrosis 11/28/2008 Designated
2244 fosgemcitabine palabenamide Treatment of biliary tract cancer 06/11/2019 Designated
2245 Fosphenytoin For the acute treatment of patients with status epilepticus of the grand mal type. 06/04/1991 Designated/Approved
2246 fostamatinib Treatment of autoimmune hemolytic anemia (AIHA) 01/31/2018 Designated
2247 fostamatinib disodium hexahydrate Treatment of immune thrombocytopenic purpura 08/25/2015 Designated/Approved
2248 fresolimumab Treatment of primary focal segmental glomerulosclerosis 10/21/2010 Designated/Withdrawn
2249 Fructose-1,6-diphosphate Treatment of painful vaso-occlusive episodes associated with sickle cell disease. 05/29/1998 Designated/Withdrawn
2250 FTV1+GDP-fucose To improve homing to bone (treatment of myeloablation) in patients receiving hematopoietic stem cell transplantation. 03/18/2011 Designated
2251 Full Phosphorothioate Antisense Oligonucleotide against EWS-Fli-1 nanoparticles Treatment of Ewing's sarcoma 09/22/2008 Designated
2252 Fully Human Anti-BCMA (B-Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cell Treatment of Multiple Myeloma 08/28/2019 Designated
2253 fully human anti-proMyostatin monoclonal antibody of the IgG4/lambda isotype that binds to human pro- and latent myostatin with high affinity Treatment of spinal muscular atrophy 03/22/2018 Designated
2254 Fully human IgG1 antibody specific for CD33 Treatment of myelodysplastic syndromes (MDS) 02/27/2017 Designated
2255 fully human IgG2 monoclonal antibody that binds insulin receptors Treatment of congenital hyperinsulinism 06/09/2015 Designated
2256 Fully human immunoglobulin G1 monoclonal antibody that targets CD32b Treatment of mantle cell lymphoma 01/29/2019 Designated
2257 fully human monoclonal antibody specific for lymphocyte activation gene 3 and nivolumab Treatment of stage IIb to IV melanoma 08/18/2017 Designated
2258 fully human nicotine-specific monoclonal antibody Treatment of thromboangiitis obliterans (Buerger’s disease) 08/22/2018 Designated
2259 fusion protein comprised of an enzymatically active Shiga-like toxin-I A1 subunit fused to a human single chain variable fragment with affinity for human CD38 cell surface protein Treatment of Multiple Myeloma 12/19/2019 Designated
2260 Fusion protein consisting of human immunoglobim G1 constant region Fc region fused to the human receptor binding domain of ectodysplasin-A1 Treatment of X-linked hypohidrotic ectodermal dysplasia 01/11/2006 Designated
2261 Fusion protein linking human frataxin to a cell-penetrant peptide Treatment of Friedreich's ataxia 07/19/2017 Designated
2262 G17DT Immunogen Treatment of gastric cancer 07/18/2002 Designated
2263 G17DT Immunogen Treatment of adenocarcinoma of the pancreas 07/10/2002 Designated
2264 gabapentin Treatment of amyotrophic lateral sclerosis 07/05/1995 Designated
2265 gabapentin Management of postherpetic neuralgia 11/08/2010 Designated/Approved
2266 gabapentin enacarbil Treatment of postherpetic neuralgia 06/07/2011 Designated/Approved
2267 Gaboxadol Treatment of Fragile X syndrome 10/03/2017 Designated
2268 galinpepimut-S Treatment of multiple myeloma 05/08/2018 Designated
2269 Gallium (68Ga) edotreotide Diagnostic for the clinical management of neuroendocrine tumors. 07/01/2015 Designated
2270 gallium citrate Treatment of lung infections in patients with cystic fibrosis 06/24/2019 Designated
2271 Gallium nitrate injection Treatment of hypercalcemia of malignancy. 12/05/1988 Designated/Approved/Withdrawn
2272 Gallium Ga-68-N-(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide Diagnostic for the clinical management of neuroendocrine tumors 12/31/2013 Designated/Approved
2273 Gallium-68 (DOTA0-Phel-Tyr3)octreotide The management of neuroendocrine tumors 10/25/2013 Designated/Approved
2274 Gallium-68 DOTANOC Diagnostic for the management of neuroblastoma 04/01/2020 Designated
2275 Gamma hydroxybutyrate Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations and automatic behavior. 12/03/1987 Designated
2276 Gamma-hydroxybutyric acid Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations, and automatic behavior. 01/22/1985 Designated/Withdrawn
2277 Gamma-hydroxybutyric acid Treatment of idiopathic hypersomnia 07/31/2019 Designated
2278 Gammalinolenic acid Treatment of juvenile rheumatoid arthritis. 07/27/1994 Designated
2279 ganaxolone Treatment of Fragile X Syndrome 12/28/2016 Designated
2280 Ganaxolone Treatment of infantile spasms. 05/25/1994 Designated
2281 ganaxolone Treatment of status epilepticus. 04/14/2016 Designated
2282 ganaxolone Treatment of cyclin-dependent kinase-like 5 (CDKL5) gene-related early-onset infantile epileptic encephalopathy 06/28/2017 Designated
2283 ganaxolone Treatment of Protocadherin 19 (PCDH19) female epilepsy. 03/24/2015 Designated
2284 ganciclovir Treatment of acute herpetic keratitis (dendritic and geographic ulcers) 03/22/2007 Designated/Approved
2285 Ganciclovir intravitreal implant Treatment of cytomegalovirus retinitis. 06/07/1995 Designated/Approved
2286 Ganciclovir sodium Treatment of cytomegalovirus retinitis in immunocompromised patients with AIDS. 10/31/1985 Designated/Approved/Withdrawn
2287 Gancyclovir Treatment of severe human cytomegalovirus infections in specific immunosuppressed patient populations. 06/07/1985 Designated/Withdrawn
2288 Gangliosides as sodium salts Treatment of retinitis pigmentosa. 11/17/1988 Designated/Withdrawn
2289 ganitumab Treatment of Ewing sarcoma. 03/21/2017 Designated
2290 ganitumab Treatment of pancreatic cancer. 11/23/2010 Designated
2291 garadacimab Treatment of bradykinin-mediated angioedema 04/30/2020 Designated
2292 Gastrin 17C Diphtheria Toxoid Immunogen Treatment of pancreatic cancer 07/07/2009 Designated
2293 Gavilimomab Acute graft-versus-host disease (aGVHD) 11/20/2000 Designated/Withdrawn
2294 gefitinib Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer 08/26/2014 Designated/Approved
2295 gemcabene Treatment of homozygous familial hypercholesterolemia 02/06/2014 Designated
2296 gemcitabine Treatment of upper tract urothelial carcinoma 12/30/2015 Designated
2297 gemcitabine Treatment of cholangiocarcinoma. 01/11/2016 Designated
2298 Gemcitabine Treatment of cholangiocarcinoma 05/18/2020 Designated
2299 gemcitabine intra-arterial infusion via the RenovoCath™ RC120 catheter Treatment of pancreatic cancer 04/24/2018 Designated
2300 gemcitabine ready-to-use Treatment of ovarian cancer 06/24/2015 Designated/Approved
2301 gemcitabine ready-to-use Treatment of pancreatic cancer 06/24/2015 Designated/Approved
2302 gemfibrozil Treatment of neuronal ceroid lipofuscinoses 08/02/2017 Designated
2303 gemfibrozil and vitamin A Treatment of neuronal ceroid lipofuscinoses 12/06/2017 Designated
2304 Gemtuzumab ozogamicin Treatment of acute myeloid leukemia 11/24/1999 Designated/Approved
2305 Gemtuzumab ozogamicin Treatment of acute myeloid leukemia 11/24/1999 Designated/Approved
2306 Gemtuzumab ozogamicin Treatment of acute myeloid leukemia 11/24/1999 Designated/Approved
2307 gene encoding chimeric CD40 ligand Treatment of chronic lymphocytic leukemia 02/04/2009 Designated
2308 generation 4 hydroxyl-terminated polyamidoamine dendrimer containing an ethylene diamine (EDA) core, amidoamine repate units, and 64 hydroxyl end groups Treatment of x-linked adrenoleukodystrophy 03/22/2017 Designated
2309 genetically engineered herpes simplex virus Treatment of medulloblastoma 05/09/2019 Designated
2310 genetically engineered herpes simplex virus Treatment of primitive neuroectodermal brain tumors 05/09/2019 Designated
2311 genetically engineered herpes simplex virus (G207) Treatment of malignant glioma 04/29/2002 Designated
2312 Genetically engineered human recombinant IgG4 monoclonal antibody directed against human TNF alpha Treatment of Crohn's disease. 12/11/1997 Designated
2313 genetically modified, non-self replicating Adeno-Associated Virus serotype 9 expressing shRNA to knock down mutant PABP1 as well as a codon optimized, shRNA-insensitive, wildtype PABN1 Treatment of oculopharyngeal muscular dystrophy (OPMD) 01/08/2018 Designated
2314 Geneticin Treatment of amoebiasis. 06/06/2005 Designated
2315 gentamicin C2 congener Treatment of cystic fibrosis 03/29/2016 Designated/Withdrawn
2316 Gentamicin impregnated PMMA beads on surgical wire Treatment of chronic osteomyelitis of post-traumatic, postoperative, or hematogenous origin. 01/31/1991 Designated
2317 Gentamicin liposome injection Treatment of disseminated Mycobacterium avium-intracellulare infection. 07/10/1990 Designated
2318 geranylgeranylacetone Prevention of Acute Radiation Syndrome 06/10/2020 Designated
2319 Geranylgeranylacetone Prevention of post-hepatectomy liver failure 06/16/2020 Designated
2320 gevokizumab Treatment of Behcet's disease 07/27/2010 Designated/Withdrawn
2321 gevokizumab Treatment of pyoderma gangrenosum 02/21/2014 Designated/Withdrawn
2322 gevokizumab Treatment of non-infectious intermediate, posterior or pan uveitis, or chronic non-infectious anterior uveitis 08/20/2012 Designated/Withdrawn
2323 gilteritinib Treatment of acute myeloid leukemia (AML) 07/13/2017 Designated/Approved
2324 Girentuximab Treatment of renal cell carcinoma. 03/22/2001 Designated
2325 Givinostat Treatment of polycythemia vera (PV) 09/28/2017 Designated
2326 givinostat Treatment of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy 04/12/2013 Designated
2327 givosiran Treatment of acute hepatic porphyria 08/29/2016 Designated/Approved
2328 glasdegib Treatment of myelodysplastic syndrome 10/20/2017 Designated
2329 Glasdegib Treatment of acute myeloid leukemia (AML) 06/28/2017 Designated/Approved
2330 glatiramer acetate Treatment of amyotrophic lateral sclerosis (ALS). 11/14/2007 Designated
2331 glatiramer acetate Treatment of multiple sclerosis 11/09/1987 Designated/Approved
2332 Glatiramer acetate for injection Treatment of primary-progressive multiple sclerosis 06/05/2001 Designated
2333 glecaprevir and pibrentasvir Treatment of pediatric patients with chronic hepatitis C virus infection 01/09/2017 Designated/Approved
2334 glepaglutide Treatment of short bowel syndrome 10/20/2017 Designated
2335 glibentek (glibenclamide oral suspension) Treatment of neonatal diabetes (monogenic forms of diabetes that present in infancy) 06/08/2016 Designated
2336 glioma derived cell lysates and irradiated cells Treatment of glioma. 01/12/2011 Designated
2337 glucagon Prevention of hypoglycemia in the congenital hyperinsulinism population 12/05/2012 Designated
2338 glucagon (ready-to-use) Treatment of hyperinsulinemic hypoglycemia (HH) 01/24/2018 Designated
2339 glucagon analog conjugated with human immunoglobulin G4 fragment Treatment of congenital hyperinsulinism (CHI) 02/01/2018 Designated
2340 glucagon infusion Prevention of chronic, severe hypoglycemia related to congential hyperinsulinism 09/25/2014 Designated
2341 Glucagon-Like Peptide 2 fused to hyFc Treatment of short bowel syndrome 10/11/2018 Designated
2342 Glucagon-like peptide-1/Glucagon/Gastric inhibitory polypeptide triple agonist linked to human IgG4 Fc fragment Treatment of primary biliary cholangitis 03/09/2020 Designated
2343 Glucagon-like peptide-1/Glucagon/Gastric inhibitory polypeptide triple agonist linked to human IgG4 Fc fragment Treatment of primary sclerosing cholangitis 03/04/2020 Designated
2344 glucarpidase Treatment of patients at risk of methotrexate toxicity 08/19/2003 Designated/Approved
2345 Glucopyranosyl lipid A stable emulsion Treatment of follicular lymphoma 02/14/2017 Designated/Withdrawn
2346 glufosfamide For treatment of pancreatic cancer. 09/18/2006 Designated
2347 Glutamine For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface). 03/06/1995 Designated/Approved
2348 Glutathione pegylated liposomal doxorubicin hydrochloride Treatment of glioma 08/16/2010 Designated
2349 glyburide Treatment of acute spinal cord injury 09/29/2015 Designated
2350 Glyburide Treatment of severe cerebral edema in patients with acute ischemic stroke 01/12/2017 Designated
2351 glyburide Treatment of acute subarachnoid hemorrhage 02/08/2016 Designated
2352 glycafilin Prevention of delayed graft function after solid organ transplantation 08/22/2008 Designated
2353 Glyceol To decrease intracranial hypertension and/or alleviate cerebral edema in patients who may benefit from osmotherapy. 02/22/1990 Designated/Withdrawn
2354 glycerol phenylbutyrate Maintenance treatment of patients with deficiencies in enzymes of the urea cycle 04/27/2009 Designated/Approved
2355 glycerol phenylbutyrate Maintenance treatment of patients with deficiencies in enzymes of the urea cycle 04/27/2009 Designated/Approved
2356 glycerol tribenzoate Treatment of Huntington’s disease 09/10/2019 Designated
2357 Glyceryl tri (4-phenylbutyrate) Treatment of spinal muscular atrophy 05/24/2005 Designated
2358 glyceryl tribenzoate Treatment of nonketotic hyperglycinemia 10/15/2019 Designated
2359 Glyceryl trioleate and glyceryl trierucate Treatment of adrenoleukodystrophy. 02/14/1995 Designated
2360 glycopyrrolate Treatment of pathologic (chronic moderate to severe) drooling in pediatric patients 06/09/2006 Designated/Approved
2361 glycopyrrolate 2% Treatment of Frey's syndrome 06/17/2010 Designated
2362 glycosylated recombinant human interleukin-7 Treatment of progressive multifocal leukoencephalopathy 09/27/2012 Designated
2363 Glyeraldehyde-3-phosphate dehydrogenase Treatment of pediatric multiple sclerosis 04/30/2010 Designated
2364 GNE Lipoplex Treatment of hereditary inclusion body myopathy-2 11/13/2008 Designated
2365 GNE plasmid(H001) Treatment of hereditary inclusion body myopathy type 2 03/26/2010 Designated
2366 golimumab Treatment of sarcoidosis 05/21/2012 Designated/Withdrawn
2367 golimumab Treatment of chronic sarcoidosis 11/02/2004 Designated/Withdrawn
2368 golimumab Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age. 04/02/2015 Designated
2369 golimumab Treatment of pediatric ulcerative colitis 03/16/2012 Designated
2370 golnerminogene pradenovec Treatment of pancreatic cancer. 10/28/2009 Designated
2371 golodirsen Treatment of Duchenne muscular dystrophy (DMD) 05/22/2018 Designated/Approved
2372 Gonadorelin acetate For induction of ovulation in women with hypothalamic amenorrhea due to a deficiency or absence in the quantity or pulse pattern of endogenous GnRH secretion. 04/22/1987 Designated/Approved
2373 Gossypol Treatment of cancer of the adrenal cortex. 10/22/1990 Designated
2374 Gp100 adenoviral gene therapy Treatment of metastatic melanoma. 03/25/1997 Designated
2375 granaticin B Treatment of Acute Lymphoblastic Leukemia (ALL) 03/07/2018 Designated
2376 Granexin® gel (aCTI peptide) Treatment of cutaneous radiation injury due to radiation disaster 08/03/2017 Designated
2377 granulocyte macrophage colony stimuling factor Treatment of cystic fibrosis 08/27/2008 Designated
2378 Granulocyte macrophage-colony stimulating factor Treatment of severe thermal injuries in patients with greater than 40% full or partial thickness burns. 06/06/1989 Designated/Withdrawn
2379 Granulocyte macrophage-colony stimulating factor Treatment of neutropenia associated with bone marrow transplants. 12/12/1989 Designated/Withdrawn
2380 Granulocyte macrophage-colony stimulating factor Treatment of myelodysplastic syndrome. 08/07/1989 Designated/Withdrawn
2381 Granulocyte macrophage-colony stimulating factor Treatment of neutropenia due to hairy cell leukemia. 05/03/1990 Designated/Withdrawn
2382 Granulocyte macrophage-colony stimulating factor Treatment of chronic lymphocytic leukemia to increase granulocyte count. 05/04/1990 Designated/Withdrawn
2383 granulocyte-macrophage colony stimulating factor-coding oncolytic adenovirus, Ad5/3-D24-GMCSF Treatment of soft tissue sarcoma 07/24/2013 Designated
2384 GRObeta (a truncated form of the human CXC motif chemokine 2) Mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent transplant 05/18/2020 Designated
2385 Group B streptococcus immune globulin Treatment of neonates for disseminated group B streptococcal infection. 05/08/1990 Designated/Withdrawn
2386 Growth hormone releasing factor For the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion. 08/07/1989 Designated
2387 growth hormone releasing hormone, 1-44 human amide Treatment of growth hormone deficiency 02/23/2016 Designated
2388 guadecitabine Treatment of acute myeloid leukemia 09/29/2015 Designated
2389 guadecitabine SC Treatment of myelodysplastic syndromes including chronic myelomonocytic leukemia 06/10/2020 Designated
2390 Guanethidine monosulfate Treatment of moderate to severe reflex sympathetic dystrophy and causalgia. 01/06/1986 Designated/Withdrawn
2391 guanfacine Treatment of fragile X syndrome. 08/05/1999 Designated
2392 guanfacine and amphetamine Treatment of pediatric patients with Tourette's syndrome (0 through 16 years of age) 03/17/2016 Designated
2393 Gusperimus Treatment of acute renal graft rejection episodes. 06/27/1996 Designated/Withdrawn
2394 gusperimus trihydrochloride Treatment of Wegener's granulomatosis 06/29/2011 Designated
2395 GVAX melanoma Treatment of stage IIb to IV melanoma 12/23/2010 Designated/Withdrawn
2396 gylceryl tri (4-pheynlybutyrate) For intermittent or chronic treatment of patients with cirrhosis and any grade hepatic encephalopathy. 09/03/2009 Designated
2397 H-(4-amino-3-iodo)-D-Phe-cCys-(3-iodo)-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2 Treatment of acromegaly 11/03/2016 Designated
2398 H-(D)p-Benzoylphenylalanyl-(D)seryl-(D)tryptophanyl-(D)seryl-(D)pentafluorophenylalanyl-(D)cyclohexylalanyl-(D)arginyl-(D)arginyl-(D)arginyl-(D)glutaminyl-(D)arginyl-(D)arginine acetate salt For use in combination with cisplatin and pemetrexed for the treatment of patients with mesothelioma 12/22/2011 Designated
2399 H-Leu-Pro-Pro-Ser-Arg-OH Treatment of Kaposi sarcoma 09/20/2012 Designated
2400 H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-alys-aleu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH Treatment of subarachnoid hemorrhage 05/14/2013 Designated
2401 H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu- Ser-Asp-Val-OH Treatment of acute ischemic stroke patients presenting within 3 hours of symptom onset 04/11/2014 Designated
2402 half-life extended bispecific T-cell engager antibody construct targeting MUC17 and CD3 Treatment of gastric cancer, including cancer of gastroesophageal junction 06/02/2020 Designated
2403 Halofantrine Treatment of mild to moderate acute malaria caused by susceptible strains of P. falciparum and P. vivax. 11/04/1991 Designated/Approved
2404 Halofuginone Treatment of systemic sclerosis. 02/07/2000 Designated
2405 halofuginone hydrobromide Treatment of Duchenne Muscular Dystrophy 10/13/2011 Designated
2406 Hanferon Treatment of Behcet's disease 03/09/2012 Designated
2407 Hantaan virus and Puumala virus DNA vaccines Prevention of hemorrhagic fever with renal syndrome caused by Hantaan virus and Puumala virus 11/13/2012 Designated
2408 HDF-LV-RTS-MMP1 (human dermal fibroblasts genetically modified with LV-RTS-MMP1) and Veledimex Treatment of localized scleroderma. 04/19/2016 Designated
2409 heat killed mycobacterium w immunomodulator Adjuvant to multi-drug therapy in the management of multibacillary leprosy 11/21/2002 Designated
2410 heat killed Mycobacterium w immunomodulator Active tuberculosis 09/03/2004 Designated
2411 heat killed mycobacterium w immunomodulator Treatment of non-small cell lung cancers that express desmocollin-3 07/31/2012 Designated
2412 heat killed whole cell mycobacterium obuense Treatment of pancreatic cancer 09/23/2014 Designated
2413 Heat Shock Protein (hsp60) antigen For use in type 1 diabetic mellitus patients with residual beta-cell function 05/21/2012 Designated/Withdrawn
2414 Heat Shock Protein 70 Treatment of amyotrophic lateral sclerosis 03/18/2011 Designated
2415 hematopoietic stem cells modified with a lentiviral vector containing the CD18 (Integrin Beta 2) gene Treatment of leukocyte adhesion deficiency Type I 11/09/2016 Designated
2416 Heme arginate Treatment of symptomatic stage of acute porphyria. 03/10/1988 Designated
2417 Heme arginate Treatment of myelodysplastic syndromes. 03/01/1994 Designated
2418 Hemin Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria. 03/16/1984 Designated/Approved
2419 Hemin and zinc mesoporphyrin Treatment of acute porphyric syndromes. 12/20/1993 Designated
2420 Hemoximer (pyridoxalated hemoglobin polyoxyethylene) Treatment of cardiogenic shock 12/18/2007 Designated
2421 heparan sulfate mimetic Treatment of pancreatic cancer 05/29/2014 Designated
2422 Heparin Treatment of cystic fibrosis 11/03/2005 Designated/Withdrawn
2423 heparin activated recombinant human fibroblast growth factor 1 (FGF1)in combination with a surgically implanted biodegradable device Treatment of patients with a confirmed traumatic complete spinal cord injury where no motor or sensory function is preserved below the injury(Scale A) 10/24/2011 Designated
2424 Heparin sodium Treatment of cystic fibrosis 06/29/2006 Designated
2425 heparin sodium Treatment of Cystic Fibrosis 07/29/2019 Designated
2426 Heparin-binding epidermal growth factor-like growth factor Prevention and treatment of necrotizing enterocolitis (NEC) in preterm infants with birth weight less than 1,500 grams 09/18/2006 Designated
2427 hepatitis B immune globulin (human) Prevention of hepatitis B recurrence following orthotopic liver transplant 03/24/2008 Designated/Approved
2428 Hepatitis B immune globulin intravenous (human) Prophylaxis against hepatitis B virus reinfection in liver transplant patients. 03/08/1995 Designated
2429 hepatitis B virus neutralizing human monoclonal antibody Prevention of hepatitis B recurrence following liver transplantation 05/06/2013 Designated
2430 Hepatitis C virus immune globulin (human) Prophylaxis of hepatitis C infection in liver transplant recipients. 11/14/2002 Designated/Withdrawn
2431 Hepcidin mimetic peptide Treatment of Polycythemia vera 06/12/2020 Designated
2432 hepcidin mimetic peptide Treatment of ß-thalassemia 03/01/2018 Designated
2433 hepcortespenlisimut-L Treatment of hepatocellular carcinoma 12/17/2014 Designated
2434 herpes simplex type 1 virus containing cellular B-myb gene as tumor-specific promoter Treatment of pancreatic cancer 12/23/2014 Designated
2435 Herpes simplex virus gene Treatment of primary and metastatic brain tumors. 10/16/1992 Designated
2436 heterodimeric fusion protein that binds to IL-1 beta consisting of human extracellular domain of IL1 receptor and a mutant Fc fragment of human IgG1 and part of human IL1 receptor accessory protein Treatment of Schnitzler Syndrome 10/15/2018 Designated
2437 heterologous human adult liver derived progenitor cells (HHALPC) Treatment of urea cycle disorders 01/13/2012 Designated
2438 heterologous human liver derived progenitor cells Treatment of Crigler-Najjar syndrome 03/09/2012 Designated
2439 hexasodium phytate Treatment of calciphylaxis 12/02/2012 Designated
2440 high molecular weight multimer of E3-Fc, an endostatin C-terminus and IgG1-Fc fusion protein Treatment of systemic sclerosis 06/27/2016 Designated
2441 highly selective histone deacetylase 6 inhibitor Treatment of Charcot-Marie-Tooth disease 03/17/2020 Designated
2442 HIRMAb-IDS Treatment of mucopolysaccharidosis Type II (Hunter Syndrome) 05/15/2013 Designated
2443 His-D-Trp-Ala-Trp-D-Phe-Lys NH2 For the long term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion. 05/23/1990 Designated/Withdrawn
2444 His-His- Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr-NH2 Treatment of retinal detachment 01/13/2016 Designated
2445 His-His-Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr Treatment of retinal detachment 03/11/2013 Designated
2446 Histamine For use as an adjunct to cytokine therapy in the treatment of malignant melanoma. 02/01/2000 Designated
2447 Histamine Adjunct to cytokine therapy in the treatment of acute myeloid leukemia. 12/15/1999 Designated
2448 Histrelin Treatment of acute intermittent porphyria, hereditary coproporphyria, and variegate porphyria. 05/03/1991 Designated
2449 Histrelin Treatment of central precocious puberty 11/18/2005 Designated/Approved
2450 Histrelin acetate Treatment of central precocious puberty. 08/10/1988 Designated/Approved
2451 HIV neutralizing antibodies Treatment of acquired immunodeficiency syndrome. 03/24/1992 Designated/Withdrawn
2452 HLA-A2-selective gp100-specific T cell redirector Treatment of uveal melanoma. 01/21/2016 Designated
2453 HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex Treatment of invasive and metastatic melanoma (Stages II, III, and IV). 09/30/1999 Designated
2454 homoharringtonine Treatment for chronic myelogenous leukemia 02/08/2002 Designated
2455 HPV-16 cancer therapeutic trojan peptide vaccine Treatment of HPV-16 expressing head and neck squamous cell carcinoma. 01/12/2009 Designated
2456 HPV16 E6/E7 synthetic long peptides vaccine Treatment of epithelial neoplasias of the vulva positive for human papilloma virus type 16. 09/01/2011 Designated
2457 Hu1D10, humanized monoclonal antibody For use in the treatment of 1D10+ B cell non-Hodgkin's lymphoma 11/28/2001 Designated
2458 Human acid precursor alpha-glucosidase, recombinant Treatment of glycogen storage disease type II. 09/10/1996 Designated/Withdrawn
2459 human allogeneic bone marrow derived osteoblastic cells Treatment of osteogenesis imperfecta. 11/09/2015 Designated
2460 human allogeneic bone marrow derived osteoblastic cells Treatment of osteonecrosis 01/10/2014 Designated
2461 Human Allogeneic HLA-matched, Umbilical Cord Blood Hematopoietic Progenitor Cells Ex Vivo Expanded on Allogeneic Mesenchymal Precursor Cells Treatment of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy. 09/12/2008 Designated
2462 Human alpha 2,6 sialyltransferase adenoviral gene therapy Treatment of patients with invasive (malignant) brain and central nervous system tumors lacking alpha 2,6 sialyltransferase. 04/04/2005 Designated
2463 Human alpha-1-antitrypsin Treatment of acute graft versus host disease 06/12/2017 Designated
2464 human Alpha1-Proteinase inhibitor Prevention of graft-versus-host disease (GVHD) 07/30/2018 Designated
2465 Human Alpha1-proteinase inhibitor Treatment of graft versus host disease 10/22/2019 Designated
2466 Human anti-CD30 monoclonal antibody Treatment of Hodgkin's disease 09/27/2004 Designated
2467 human anti-CD4 monoclonal antibody Treatment of mycosis fungoides 08/13/2004 Designated
2468 human anti-cellular adhesion molecule-1 monoclonal antibody Treatment of multiple myeloma 07/29/2008 Designated
2469 Human anti-integrin receptor av monoclonal antibody Treatment of patients with angiosarcoma 05/05/2005 Designated/Withdrawn
2470 human anti-integrin receptor avb3/avb5 monoclonal antibody Treatment of patients with high-risk stage II, stage III, and stage IV malignant melanoma 12/01/2004 Designated/Withdrawn
2471 human anti-transforming growth factor beta 1 monoclonal antibody Treatment of systemic sclerosis 01/11/2002 Designated/Withdrawn
2472 human anti-transforming growth factor-B1,2,3 Treatment of idiopathic pulmonary fibrosis 07/09/2004 Designated/Withdrawn
2473 Human Anti-tumor Necrosis factor alpha monoclonal antibody Treatment of uveitis of the posterior segment of non-infectious etiology, and uveitis of the anterior segment of non-infectious etiology and refractory to conventional therapy 01/16/2003 Designated/Withdrawn
2474 human astrocytes derived from astrocyte progenitor cells originating from clincial-grade human embryonic stem cells Treatment of amyotrophic lateral sclerosis 11/01/2018 Designated
2475 Human autologous bone-forming cell derived from bone marrow stem cells Treatment of osteonecrosis 03/24/2008 Designated/Withdrawn
2476 human coagulation factor VIII Immune tolerance induction in hemophilia A patients with inhibitors 12/03/2012 Designated/Withdrawn
2477 human coagulation factor XI Treatment of congenital factor XI deficiency 02/15/2018 Designated
2478 human coagulation factor XI Treatment of severe congential Factor XI deficiency. 11/08/2007 Designated/Withdrawn
2479 human cystic fibrosis transmembrane conductance regulator (hCFTR) messenger RNA (mRNA) complexed with branched polyethyleneimine (bPEI) Treatment of patients with cystic fibrosis. 11/03/2015 Designated
2480 Human cytomegalovirus (HCMV) internal repeat short 1 (IRS1)-expressing oncolytic Herpes Simplex Virus Treatment of malignant glioma 05/09/2019 Designated
2481 Human cytomegalovirus immunoglobulin Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women 12/20/2006 Designated
2482 human donor hematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with TBX-4000 Enhancement of cell engraftment in patients receiving hematopoietic stem cell transplant. 06/02/2016 Designated
2483 human fibrinogen concentrate, pasteurized Treatment of fibrinogen deficient patients. 03/13/2008 Designated/Approved
2484 human fully IgG1 antibody specific for CD33 Treatment of acute myeloid leukemia 06/19/2014 Designated
2485 human gammaglobulin Treatment of idiopathic inflammatory myopathies 11/14/2003 Designated
2486 human gammaglobulin Treatment of gastrointestinal disturbances (to include constipation, diarrhea, and abdominal pain) associated with regression-onset autism in pediatric patients. 09/16/2002 Designated
2487 human gammaglobulin Treatment for juvenile rheumatoid arthritis 05/25/2001 Designated
2488 human glial restricted progenitor cells and their progeny Treatment of amyotrophic lateral sclerosis 09/11/2013 Designated
2489 human glial restricted progenitor cells and their progeny Treatment of transverse myelitis 04/11/2018 Designated
2490 human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment (ready to use pre-filled syringe) Treatment of short bowel syndrome 05/01/2019 Designated
2491 human haptoglobin Treatment of sickle cell disease 11/19/2013 Designated
2492 Human Hemin Prevention of ischemia reperfusion injury in patients undergoing solid organ transplantation 08/06/2013 Designated
2493 human Hepatocarcinoma-Intestine-pancreas/pancreatitis associated protein Treatment of acute liver failure 05/11/2011 Designated
2494 human heterologous liver cells Treatment of urea cycle disorders 02/14/2011 Designated
2495 human IgG1 anti-human cytomegalovirus monoclonal antibodies LJP538 and LJP539 Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women 10/18/2017 Designated
2496 Human IgG1 monoclonal antibody to human CD38 Treatment of multiple myeloma 01/22/2019 Designated
2497 human IgG1k monoclonal antibody Treatment of systemic sclerosis 10/16/2013 Designated
2498 human IgG2 anti-monoclonal antibody directed against mucosal addressin cell adhesion molecule (MAdCAM) Treatment of pediatric patients with Ulcerative Colitis (UC) 11/16/2017 Designated
2499 human IgG2 monoclonal antibody directed against the mucosal addressin cell adhesion molecule Treatment of Crohn’s Disease (CD) in the pediatric population 02/07/2018 Designated
2500 human IgG4-based anti-CD20 x anti-CD3 bispecific monoclonal antibody Treatment of diffuse large b-cell lymphoma. 06/06/2017 Designated
2501 Human IgM monoclonal antibody (C-58) To CMV Prophylaxis of cytomegalovirus infections in bone marrow transplant patients. 08/07/1989 Designated/Withdrawn
2502 Human IgM monoclonal antibody (C-58) To CMV Treatment of cytomegalovirus infections in allogenic bone marrow transplant patients. 08/07/1989 Designated/Withdrawn
2503 Human immune globulin Treatment of post-polio syndrome 03/29/2006 Designated
2504 Human immunodeficiency virus immune globulin Treatment of HIV-infected pediatric patients. 01/04/1995 Designated/Withdrawn
2505 Human immunodeficiency virus immune globulin Treatment of HIV-infected pregnant women and infants of HIV-infected mothers. 03/25/1992 Designated/Withdrawn
2506 Human immunodeficiency virus immune globulin Treatment of AIDS. 11/21/1989 Designated/Withdrawn
2507 Human immunoglobin anti-CD30 monoclonal antibody Treatment of CD30+ T-cell lymphoma 01/10/2006 Designated
2508 human immunoglobulin (IgG1K) monoclonal antibody that binds to interleukin 15 Treatment of refractory celiac disease. 04/10/2018 Designated
2509 human insulin (rDNA) Treatment of short bowel syndrome (SBS). 04/06/2015 Designated
2510 human insulin beta chain peptide with incomplete Freund's adjuvant vaccine Treatment of Type 1 diabetes patients with residual beta cell function 02/11/2013 Designated
2511 human interleukin-3 genetically conjugated to diphtheria toxin protein Treatment of acute myeloid leukemia. 02/18/2011 Designated
2512 human laminin-111 Treatment of merosin (laminin-alpha2) deficient congential muscular dystrophy type 1A. 09/23/2011 Designated
2513 human leukocyte antigen-A2 restricted peptides Treatment of glioma 01/26/2015 Designated
2514 human leukocyte-derived cytokine mixture Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck 07/07/2005 Designated
2515 Human major histocompatibility complex (MHC) non-restricted T-cell line 104 Treatment of multiple myeloma 04/17/2017 Designated
2516 human MHC non-restricted cytotoxic T-cell line Treatment of ovarian cancer 07/06/2012 Designated
2517 human monoclonal anti-PA antibody For post-exposure prophylaxis and treatment of inhalation anthrax. 10/21/2010 Designated/Withdrawn
2518 Human monoclonal antibody against phosphorylcholine Prevention of arteriovenous fistula or arteriovenous graft failure in patients with end stage renal disease receiving hemodialysis or preparing for hemodialysis 06/15/2017 Designated
2519 Human monoclonal antibody against platelet-derived growth factor D To slow the progression of IgA nephropathy and delay kidney failure in patients affected by the disease. 11/02/2004 Designated
2520 human monoclonal antibody againt human interleukin 13 (IL-13) Treatment of eosinophilic esophagitis 10/15/2013 Designated
2521 Human monoclonal antibody directed against human Activin A Treatment of fibrodysplasia ossificans progressiva 01/19/2017 Designated
2522 Human monoclonal antibody directed against serotype 011 Pseudomonas aeruginosa Treatment of hospital acquired pneumonia caused by serotype 011 positive Pseudomonas aeruginosa 09/18/2006 Designated
2523 human monoclonal antibody directed against serotype O1 Pseudomonas aeruginosa Treatment of pneumonia caused by serotype O1 positive Pseudomonas aeruginosa 01/06/2010 Designated
2524 human monoclonal antibody directed against tissue factor pathway inhibitor Treatment of hemophilia A and hemophilia B patients with or without inhibitors, which includes routine prophylaxis to prevent or reduce the frequency of bleeding in hemophilia A and hemophilia B patients. 05/18/2016 Designated
2525 human monoclonal antibody inhibitor of mannan binding lectin-associated serine protease-2 Treatment of immunoglobulin A nephropathy (IgAN) 08/03/2017 Designated
2526 Human monoclonal antibody inhibitor of mannan binding lectin-associated serine protease-2 (MASP-2) Prevention (inhibition) of complement-mediated thrombotic microangiopathy 12/16/2013 Designated
2527 human monoclonal antibody inhibitor of mannan binding lectin-associated serine protease-2 (MASP-2) Treatment of Hematopoietic Stem-Cell Transplant-Associated Thrombotic Microangiopathy 10/22/2018 Designated
2528 Human monoclonal antibody targeting CC-chemokine ligand 2 (CNTO 888) Treatment of ovarian cancer 04/30/2010 Designated
2529 human monoclonal antibody targeting human sclerostin Treatment of osteogenesis imperfecta. 02/29/2016 Designated
2530 Human Placental Extract Prevention of necrotizing enterocolitis in early preterm infants (gestational age less than 34 weeks). 05/28/2020 Designated
2531 Human plasma coagulation Factor VIII and human plasma von Willebrand Factor Treatment of von Willebrand disease except for surgical and/or invasive procedures in patients with von Willebrand disease in whom desmopressin is either ineffective or contraindicated 04/18/2007 Designated/Approved
2532 Human plasma derived conagulation protein-Factor XI For the treatment of congenital Factor XI deficiency 04/30/2014 Designated
2533 human plasminogen Treatment of ligneous conjunctivitis 06/07/2010 Designated
2534 human platelet antigen-1a immunoglobulin (anti-HPA-1a) Prevention of fetal and neonatal alloimmune thrombocytopenia 06/27/2013 Designated
2535 human platelet derived hemostatic agent Treatment of Acute Radiation Syndrome 05/07/2020 Designated
2536 Human prothrombin complex concentrate Reversal of anticoagulation therapy in patients needing treatment of serious or life threatening bleeding and/or needing urgent surgery or invasive procedures 02/01/2008 Designated
2537 human recombinant bone morphogenetic protein 4 Treatment of glioblastoma multiforme. 05/04/2016 Designated
2538 human recombinant DNA-derived, IgG1 kappa monoclonal anti-body to connective growth factor Treatment of idiopathic pulmonary fibrosis 07/06/2012 Designated
2539 human recombinant dual-variable domain immunoglobulin G1 monoclonal antibody that selectively neutralizes tumor necrosis factor-alpha and interkeukin-17A Treatment of pediatric patients 0 to <18 yrs of age with oligoarticular-course and polyarticular-course juvenile idiopathic arthritis. 02/04/2016 Designated/Withdrawn
2540 human recombinant mesencephalic, astrocyte derived neurotrophic factor Treatment of retinitis pigmentosa 12/22/2014 Designated
2541 human retinal progenitor cells Treatment of retinitis pigmentosa 07/23/2012 Designated
2542 human single domain antibody-like protein inhibitor of the chemokine receptor type 4 Treatment of idiopathic pulmonary fibrosis 01/11/2017 Designated
2543 human soluble receptor-Fc fusion protein that targets human activin A Treatment of ovarian cancer. 10/14/2015 Designated
2544 human spinal cord derived neural stem cells Treatment of amyotrophic lateral sclerosis 02/04/2011 Designated
2545 Human T-lymphotropic virus type III Gp160 antigens Treatment of AIDS. 11/20/1989 Designated
2546 Human telomerase reverse transcriptase peptide vaccine Treatment of pancreatic cancer 07/20/2006 Designated
2547 human tumor necrosis factor coupled to the C terminus of CNGRCG peptide Treatment of liver cancer 10/01/2009 Designated
2548 human umbilical cord blood-derived mesenchymal stem cells Prevention of bronchopulmonary dysplasia 11/26/2013 Designated
2549 human umbilical tissue derived cells (hUTC) Treatment of amyotrophic lateral sclerosis 05/10/2011 Designated/Withdrawn
2550 Human umbilical tissue-derived cells Treatment of retinitis pigmentosa 03/13/2006 Designated/Withdrawn
2551 Human Wilms tumor protein 1 peptides Treatment of acute myeloid leukemia 12/23/2015 Designated
2552 Human wilms tumor protein 1 peptides treatment of mesothelioma 02/23/2016 Designated
2553 Human/Murine Chimeric Monoclonal antibody to Endoglin Treatment of soft tissue sarcoma. 01/20/2016 Designated/Withdrawn
2554 humanized anti CD20 monoclonal antibody Treatment of Dermatomyositis 06/11/2019 Designated
2555 Humanized anti-BCMA (B-cell maturation antigen) monoclonal antibody Treatment of multiple myeloma 06/22/2017 Designated
2556 humanized anti-CD19, Fc engineered, monoclonal antibody with enhanced binding to FcyRIIb Treatment of immunoglobulin G4-related disease 05/09/2017 Designated
2557 Humanized anti-CD2 monoclonal antibody Treatment of graft-versus-host disease. 11/13/1998 Designated/Withdrawn
2558 humanized anti-CD40LG IgG1, kappa monoclonal antibody with heavy chain C220S/C226S/C229S/P238S substitutions to attenuate effector function Treatment of Amyotrophic Lateral Sclerosis (ALS) 04/04/2018 Designated
2559 humanized anti-Globo H monoclonal antibody Treatment of pancreatic cancer 11/20/2018 Designated
2560 Humanized Anti-Globo H Monoclonal Antibody Monomethyl Auristatin E Conjugate Treatment of Pancreatic cancer 12/23/2019 Designated
2561 Humanized Anti-Globo H Monoclonal Antibody Monomethyl Auristatin E Conjugate Treatment of Gastric cancer 01/15/2020 Designated
2562 humanized anti-human CD16 monoclonal antibody Treatment of adult idiopathic thrombocytopenic purpura 03/21/2005 Designated/Withdrawn
2563 Humanized anti-human CD2 MAb For the induction of donor-specific immunologic unresponsiveness resulting in prophylaxis of organ rejection without the need for chronic immunosuppressive therapy, in patients receiving allogeneic renal transplants. 09/17/1998 Designated/Withdrawn
2564 Humanized anti-tac Prevention of acute graft-vs-host disease following bone marrow transplantation. 03/05/1993 Designated
2565 humanized bi-specific XmAb(R) T cell recruiting antibody construct directed against CD3 and CD38 Treatment of multiple myeloma 11/14/2019 Designated
2566 Humanized connexin 43 (hCx43) monoclonal antibody Treatment of Osteosarcoma 09/18/2019 Designated
2567 humanized connexin 43 monoclonal antibody Treatment of acute spinal cord injury 11/20/2018 Designated
2568 humanized Fc engineered monoclonal antibody against CD19 Treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma 04/29/2014 Designated
2569 Humanized IgG-1 antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase Treatment of Mucopolysaccharidosis Type II (MPS II) or Hunter Syndrome 10/15/2018 Designated
2570 humanized IgG1 anti-serum amyloid A monoclonal antibody Treatment of AA amyloidosis and AL amyloidosis 02/17/2012 Designated
2571 humanized IgG1 antibody specifific for the AXL tyrosine kinase conjugated to monomethyl auristatin E Treatment of pancreatic cancer 11/19/2018 Designated
2572 humanized IgG1 low affinity allergic reactivity inhibiting (LARI) monoclonal antibody Treatment for mastocytosis 02/15/2018 Designated
2573 humanized IgG1 monoclonal anti-CD20 antibody Treatment of follicular lymphoma 05/26/2011 Designated
2574 humanized IgG1 monoclonal antibody targeting KIR3DL2 Treatment of cutaneous T-cell lymphoma. 06/14/2017 Designated
2575 humanized IgG4 kappa monoclonal antibody comprised of 2 identical light chains and 2 identical heavy chains fused to attenuated interferon alpha 2b Treatment of Multiple Myeloma 02/28/2019 Designated
2576 humanized IgG4 monoclonal antibody Prevention of ischemia/reperfusion injury associated with solid organ tranplantation 12/12/2011 Designated
2577 Humanized IgG4 monoclonal antibody against total complement component 1, subcomponent s Treatment of immune thrombocytopenia 03/28/2018 Designated
2578 humanized IgG4 Monoclonal Antibody against total complement component 1, subcomponent s (C1s) Treatment of bullous pemphigoid (BP). 08/17/2017 Designated
2579 humanized IgG4 monoclonal antibody binding to human C1q Treatment of Guillain-Barre Syndrome 01/19/2017 Designated
2580 humanized IgG4 monoclonal antibody optimized for neutralizing activity against DKK1, a secreted modulator of Wnt signaling Treatment of gastric and gastroesophageal junction cancer 06/10/2020 Designated
2581 Humanized IgG4 monoclonal antibody that antagonizes endothelin-1 receptor subtype A Treatment of pulmonary arterial hypertension (PAH) 06/06/2017 Designated
2582 humanized IgG4 monoclonal antibody that binds to the SEMA4D antigen Treatment of Huntington's disease 08/16/2016 Designated
2583 humanized IgG4 monoclonal antibody to Toll-Like Receptor 2 (TLR2) Treatment of myelodysplastic syndrome 08/30/2016 Designated
2584 Humanized IgG4 S228P monoclonal antibody targeting the cis conformation of the phosphorylated Thr231-Pro232 motif in tau Treatment of Progressive supranuclear palsy 06/16/2020 Designated
2585 humanized IgG4-based anti-CD20 x anti-CD3 bispecific monoclonal antibody Treatment of follicular lymphoma 01/25/2018 Designated
2586 humanized immunoglobulin (Ig)G1k-agonistic monoclonal antibody (mAb) that binds to CD40 Treatment of pancreatic cancer 03/09/2020 Designated
2587 humanized immunoglobulin G1 (IgG1) T-cell bispecific (TCB) antibody targeting carcinoembryonic antigen (CEA) Treatment of gastric cancer, including gastroesophageal junction cancer 01/22/2018 Designated
2588 humanized immunoglobulin G1 (IgG1) T-cell bispecific (TCB) antibody targeting carcinoembryonic antigen (CEA) and CD3 epsilon chain (CD3e) on T-cells Treatment of pancreatic cancer 07/27/2017 Designated
2589 humanized immunoglobulin G4-variant monoclonal antibody directed against the p19 subunit of interleukin (IL)-23 Treatment of pediatric Crohn's disease 07/06/2017 Designated
2590 humanized immunoglobulin G4-variant monoclonal antibody directed against the p19 subunit of interleukin (IL)-23 Treatment of ulcerative colitis in pediatric patients 06/15/2017 Designated
2591 Humanized MAb (IDEC-131) to CD40L Treatment of systemic lupus erythematosus. 02/09/1999 Designated/Withdrawn
2592 humanized monoclonal antibodies hu1B7 and hu11E6 Treatment of Bordetella pertussis 09/11/2014 Designated
2593 humanized monoclonal antibody against human integrin alphaVbeta6 Treatment of idiopathic pulmonary fibrosis 08/05/2010 Designated
2594 humanized monoclonal antibody against human PD-1 Treatment of neuroendocrine tumors 06/08/2017 Designated
2595 humanized monoclonal antibody against Shiga-like toxin II To prevent the development of or to decrease the incidence and severity of hemolytic uremic syndrome and associated sequelae of Shiga-like toxin-producing E. coli. 09/12/2001 Designated/Withdrawn
2596 humanized monoclonal antibody of the IgG4 kappa isotype targeting CD47 Treatment of acute myeloid (myelogenous) leukemia. 08/20/2015 Designated
2597 humanized monoclonal antibody targeting interleukin-15 Treatment of eosinophilic esophagitis 10/25/2018 Designated
2598 humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473) Treatment of acute myeloid leukemia 05/05/2015 Designated
2599 humanized monoclonal antibody to CCR5 Prevention of graft versus host disease 10/04/2017 Designated
2600 humanized monoclonal antibody to tissue factor Treatment of pancreatic cancer. 04/26/2011 Designated/Withdrawn
2601 Humanized monoclonal antibody to TumorEndothelial Marker-1 Treatment of soft tissue sarcoma 04/29/2011 Designated
2602 humanized monoclonal IgG1 antibody (mAb) against human interleukin (IL)36R Treatment of generalized pustular psoriasis 10/03/2018 Designated
2603 Humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker Treatment of diffuse large B-cell lymphoma 06/08/2017 Designated
2604 Humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through a protease cleavable valine-alanine linker Treatment of mantle cell lymphoma 06/08/2017 Designated
2605 humanized monocloncal antibody against human integrin alphaVbeta6 Treatment of fibrosis-associated chronic allograft nephropathy in kidney transplant patients. 06/18/2008 Designated
2606 humanized non-fucosylated anti-siglec-8 monoclonal antibody (IgG1) Treatment of eosinophilic gastritis 02/01/2018 Designated
2607 humanized non-fucosylated Anti-Siglec-8 Monoclonal Antibody (IgG1) Treatment of eosinophilic gastroenteritis 02/01/2018 Designated
2608 humanized non-fucosylated anti-Siglec-8 monoclonal antibody (IgG1) Treatment of Mastocytosis 07/15/2019 Designated
2609 humanized single chain monoclonal antibody(scFV: IgG1 hinge: IgG1 CH2 and CH3 domains) Treatment of chronic lymphocytic leukemia 11/17/2011 Designated
2610 humanized, bispecific IgG1-like antibody directed against HER2 Treatment of Biliary Tract Cancer 12/18/2019 Designated
2611 Huperzine A Treatment of Dravet syndrome 04/12/2017 Designated
2612 hyaluronic acid Treatment of emphysema in patients due to alpha-1 antitrypsin deficiency 03/19/2002 Designated
2613 hyaluronic acid Treatment of emphysema due to alpha1-antitrypsin deficiency. 01/18/2017 Designated
2614 Hydralazine Treatment of severe intrapartum hypertension (diastolic blood pressure greater than or equal to 110 or systolic blood pressure greater than or equal to 160) associated with severe preeclampsia/eclampsia of pregnancy 04/09/2004 Designated
2615 hydralazine - magnesium valproate Treatment of cutaneous T-cell lymphoma. 03/17/2011 Designated
2616 hydralazine - magnesium valproate Treatment of myelodysplastic syndrome 03/17/2011 Designated
2617 hydrocinnamate-Orn-Pro-dCha-Trp-Arg(CH3COO) Treatment of amyotrophic lateral sclerosis 03/09/2015 Designated
2618 hydrocortisone Prevention of bronchopulmonary dysplasia 05/13/2020 Designated
2619 hydrocortisone acetate Treatment of pediatric ulcerative colitis 06/27/2017 Designated
2620 hydrocortisone modified release capsules Treatment of congenital adrenal hyperpasia 03/18/2015 Designated
2621 hydrocortisone modified release capsules Treatment of adrenal insufficiency. 09/03/2015 Designated
2622 hydrocortisone modified release tabs Treatment of adrenal insufficiency 06/18/2008 Designated
2623 hydrocortisone oral granules Treatment of pediatric adrenal insufficiency (0 through 16 years of age). 05/13/2015 Designated
2624 hydromethylthionine mesylate Treatment of frontotemporal dementia 11/20/2018 Designated
2625 hydromorphone hydrochloride (intrathecal infusion) Treatment of complex regional pain syndrome 06/16/2016 Designated
2626 Hydroxocobalamin Treatment of acute cyanide poisoning 11/25/2003 Designated/Approved
2627 Hydroxocobalamin Treatment of acute cyanide poisoning 09/22/2000 Designated
2628 Hydroxy-Propyl-Beta-Cyclodextrin Treatment of Niemann Pick Disease, Type C 05/17/2010 Designated
2629 hydroxycarbamide (hydroxyurea) Treatment of sickle cell disease in patients under 18 years of age 07/24/2013 Designated/Approved
2630 Hydroxycobalamin/sodium thiosulfate Treatment of severe acute cyanide poisoning. 10/04/1985 Designated/Withdrawn
2631 hydroxypioglitazone Treatment of X-linked adrenoleukodystrophy 01/30/2017 Designated
2632 hydroxyprogesterone caproate Prevention of preterm birth in singleton pregnancies 01/25/2007 Designated/Approved
2633 hydroxyprogesterone caproate Prevention of preterm birth in singleton pregnancies 01/25/2007 Designated/Approved
2634 hydroxypropyl-B-cyclodextrin-panobinostat complex Treatment of malignant glioma 10/22/2019 Designated
2635 hydroxyurea Treatment of symptomatic sickle cell disease in pediatric patients, less than 17 years of age. 03/16/2015 Designated
2636 hydroxyurea Treatment of pediatric patients with sickle cell anemia. 04/15/2005 Designated
2637 Hydroxyurea Treatment of patients with sickle cell anemia as shown by the presence of hemoglobin S. 10/01/1990 Designated/Approved
2638 Hydroxyurea Treatment of sickle cell anemia in pediatric patients 03/02/2017 Designated
2639 Hypericin Treatment of glioblastoma multiforme. 08/03/2000 Designated
2640 hypericin Treatment of cutaneous T-cell lymphoma 02/07/2000 Designated
2641 Hypothiocyanite and lactoferrin Treatment of cystic fibrosis 11/05/2009 Designated
2642 Hypotonic, acid oxidizing solution containing hypochlorous acid (HClO) Treatment of Epidermolysis Bullosa 11/26/2019 Designated
2643 I(131)-TM-601 (chlorotoxin) Treatment of malignant glioma 02/14/2002 Designated
2644 ibalizumab Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy 10/20/2014 Designated/Approved
2645 iberdomide Treatment of multiple myeloma 12/19/2018 Designated
2646 Iboctadekin Treatment of renal cell carcinoma 06/03/2005 Designated/Withdrawn
2647 ibritumomab tiuxetan Treatment of B-cell non-Hodgkin's lymphoma. 09/06/1994 Designated/Approved
2648 ibrutinib Treatment of chronic lymphocytic leukemia (CLL). 03/27/2012 Designated/Withdrawn
2649 ibrutinib Treatment of small lymphocytic lymphoma 05/30/2013 Designated/Approved
2650 ibrutinib Treatment of diffuse large B-cell lymphoma 10/23/2013 Designated
2651 ibrutinib Treatment of multiple myeloma 05/16/2013 Designated
2652 ibrutinib Treatment of mantle cell lymphoma 12/03/2012 Designated/Approved
2653 ibrutinib Treatment of chronic lymphocytic leukemia (CLL) 04/06/2012 Designated/Approved
2654 ibrutinib Treatment of chronic lymphocytic leukemia (CLL) 04/06/2012 Designated/Approved
2655 ibrutinib Treatment of chronic lymphocytic leukemia (CLL) 04/06/2012 Designated/Approved
2656 ibrutinib Treatment of follicular lymphoma 09/08/2014 Designated
2657 ibrutinib Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma 02/01/2018 Designated
2658 ibrutinib Treatment of Waldenstrom's macroglobulinemia 10/15/2013 Designated/Approved
2659 ibrutinib Treatment of pancreatic cancer 06/12/2017 Designated
2660 ibrutinib Treatment of nodal marginal zone lymphoma 02/05/2015 Designated/Approved
2661 ibrutinib Treatment of patients with extranodal marginal zone lymphoma (mucosa associated lymphoid tissue MALT type lymphoma) 02/02/2016 Designated/Approved
2662 ibrutinib Treatment of chronic Graft versus Host disease. 06/23/2016 Designated/Approved
2663 ibrutinib Treatment of splenic marginal zone lymphoma 02/05/2015 Designated/Approved
2664 ibudilast Treatment of amyotrophic lateral sclerosis 10/06/2016 Designated
2665 ibudilast Treatment of Krabbe disease 06/01/2015 Designated
2666 Ibudilast Treatment of Glioblastoma 10/02/2018 Designated
2667 Ibuprofen i.v. solution Prevention of patent ductus arteriosus. 10/29/1996 Designated
2668 Ibuprofen lysine Treatment of patent ductus arteriosus 10/29/1996 Designated/Approved
2669 ibutamoren mesylate Treatment of growth hormone deficiency 06/15/2017 Designated
2670 icatibant Treatment of angioedema 11/25/2003 Designated/Approved
2671 icatibant Treatment of burn patients hospitalized with burn-induced edema 05/05/2004 Designated/Withdrawn
2672 ICG136:CD123-CD33cCAR T-cells Treatment of acute myeloid leukemia 09/19/2017 Designated
2673 ICG140:CD19-CD123 cCAR T-cells, a chimeric antigen receptor (CAR) on the surface of T-cells directed against the target proteins CD19 and CD 123 Treatment of acute lymphoblastic leukemia 12/26/2017 Designated
2674 iclaprim Treatment of Staphylococus aureus lung infections in patients with cystic fibrosis 09/14/2017 Designated
2675 Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment. 07/18/1997 Designated/Approved
2676 Idarubicin Treatment of chronic myelogenous leukemia. 12/02/1992 Designated/Withdrawn
2677 Idarubicin Treatment of myelodysplastic syndromes. 12/01/1992 Designated/Withdrawn
2678 Idarubicin HCl for injection Treatment of acute lymphoblastic leukemia in pediatric patients. 02/12/1991 Designated/Withdrawn
2679 Idarubicin HCl for injection Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia. 07/25/1988 Designated/Approved
2680 idarucizumab To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure 05/28/2015 Designated/Approved
2681 idasanutlin Treatment of polycythemia vera 11/29/2017 Designated/Withdrawn
2682 idebenone Treatment of Duchenne muscular dystrophy 02/16/2007 Designated
2683 idebenone Treatment of mitochondrial myopathy, encephalopathy, lactic acidosis with stroke-like episodes syndrome (MELAS) 05/22/2009 Designated/Withdrawn
2684 idebenone Treatment of Leber's hereditary optic neuropathy. 10/31/2006 Designated
2685 idebenone Treatment of Friedreich's ataxia 03/25/2004 Designated
2686 idelalisib Treatment of nodal marginal zone lymphoma. 10/15/2013 Designated
2687 idelalisib Treatment of lymphoplasmacytic lymphoma with or without Walenstrom's macroglobulinemia 09/26/2013 Designated
2688 idelalisib Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma 10/15/2013 Designated/Approved
2689 idelalisib Treatment of follicular lymphoma 09/26/2013 Designated/Approved
2690 idelalisib Treatment of chronic lymphocytic leukemia 08/25/2011 Designated
2691 idelalisib Treatment of splenic marginal zone lymphoma 10/15/2013 Designated
2692 idelalisib Treatment of extranodal marginal zone lymphoma 10/15/2013 Designated
2693 Idoxuridine Treatment of nonparenchymatous sarcomas. 04/08/1996 Designated
2694 IDUA-HIRMAb fusion protein Treatment of mucopolysaccharidosis Type 1 (MPS) 01/10/2008 Designated
2695 idursulfase Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome) 11/28/2001 Designated/Approved
2696 idursulfase beta Treatment of Hunter Syndrome (mucopolysaccharidoses) 02/11/2013 Designated
2697 idursulfase IT For treatment of neurocognitive symptoms associated with Hunter Syndrome 09/03/2009 Designated
2698 iduvec Treatment of Mucopolysaccharidosis Type I 01/21/2011 Designated
2699 iferanserin (S-MPEC) For use in pulmonary arterial hypertension. 12/13/2010 Designated
2700 ifosfamide Treatment of soft tissue and bone sarcomas 08/07/1985 Designated
2701 Ifosfamide Treatment of testicular cancer. 01/20/1987 Designated/Approved
2702 IgG1 chimeric monoclonal antibody Treatment of multiple myeloma. 06/22/2011 Designated
2703 IL-12 secreting dendritic cells loaded with autologous tumor lysate Treatment of malignant glioma 06/24/2013 Designated
2704 IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-PE38KDEL) Treatment of astrocytic glioma. 04/06/2000 Designated
2705 iloprost Treatment of pulmonary arterial hypertension 04/06/2012 Designated
2706 iloprost Treatment of systemic sclerosis 05/09/2019 Designated
2707 Iloprost inhalation solution Treatment of pulmonary arterial hypertension 08/17/2004 Designated/Approved
2708 Iloprost solution for infusion Treatment of heparin-associated thrombocytopenia. 05/14/1990 Designated/Withdrawn
2709 Iloprost solution for infusion Treatment of Raynaud's phenomenon secondary to systemic sclerosis. 09/21/1989 Designated/Withdrawn
2710 ilorasertib Treatment of ovarian cancer 03/16/2012 Designated/Withdrawn
2711 imatinib Treatment of Philadelphia-positive acute lymphoblastic leukemia 10/11/2005 Designated/Approved
2712 imatinib Treatment of Philadelphia-positive acute lymphoblastic leukemia 10/11/2005 Designated/Approved
2713 Imatinib Treatment of chronic myelogenous leukemia 01/31/2001 Designated/Approved
2714 imatinib Treatment of pulmonary arterial hypertension 04/07/2010 Designated/Withdrawn
2715 Imatinib mesylate Treatment of idiopathic hypereosinophilic syndrome including acute and chronic eosinophilic leukemia 08/25/2005 Designated/Approved
2716 imatinib mesylate Treatment of gastrointestinal stromal tumors 11/01/2001 Designated/Approved
2717 Imatinib mesylate Treatment of systemic mastocytosis without the D816V c-kit mutation 09/09/2005 Designated/Approved
2718 imatinib mesylate Treatment of dermatofibrosarcoma protuberans 12/19/2005 Designated/Approved
2719 imatinib mesylate Treatment of progressive multifocal leukencephalopathy 05/06/2014 Designated
2720 imatinib mesylate Treatment of pulmonary arterial hypertension 06/15/2020 Designated
2721 imatinib mesylate Treatment of gastrointestinal stromal tumors 11/01/2001 Designated/Approved
2722 Imatinib mesylate Treatment of myeloproliferative disorders/myelodysplastic syndromes associated with platelet-derived growth factor gene re-arrangements 10/05/2005 Designated/Approved
2723 Imciromab pentetate Detecting early necrosis as an indication of rejection of orthotopic cardiac transplants. 01/25/1989 Designated
2724 imetelstat Treatment of myelodysplastic syndrome 12/23/2015 Designated
2725 imetelstat Treatment of myelofibrosis 06/11/2015 Designated
2726 imexon Treatment of ovarian cancer. 08/12/2005 Designated
2727 Imexon Treatment of pancreatic adenocarcinoma 11/01/2003 Designated/Withdrawn
2728 Imexon Treatment of multiple myeloma. 11/08/1996 Designated
2729 Imexon Treatment of metastatic malignant melanoma 08/03/2001 Designated/Withdrawn
2730 imidazolyl ethanamide pentandioic acid Treatment of Acute Radiation Syndrome 09/17/2018 Designated
2731 Imidazopyridine Treatment of Amyotrophic Lateral Sclerosis 07/22/2019 Designated
2732 Imiglucerase Replacement therapy in patients with types I, II, and III Gaucher's disease. 11/05/1991 Designated/Approved
2733 Imiquimod Treatment of carcinoma in situ (CIS) of the urinary bladder 12/03/2014 Designated
2734 Imlifidase Treatment of anti-glomerular basement membrane (anti-GBM) disease 07/03/2018 Designated
2735 imlifidase Treatment of Guillain-Barré Syndrome (GBS) 02/14/2018 Designated
2736 Immortalized human liver cells found in the extracorporeal liver assist device Treatment of fulminant hepatic failure (acute liver failure) 07/16/2004 Designated
2737 immune globulin (human) Treatment of Myasthenia Gravis 12/12/2016 Designated
2738 immune globulin (human) Treatment of Guillain-Barre syndrome 03/02/2010 Designated
2739 Immune Globulin (Human) Treatment of chronic inflammatory demyelinating polyneuropathy 07/27/2004 Designated/Approved
2740 Immune Globulin (Human) containing high titers of West Nile virus antibodies Treatment of the West Nile virus infection 03/17/2004 Designated
2741 immune globulin infusion (human) Treatment of multifocal motor neuropathy 07/20/2006 Designated/Approved
2742 immune globulin infusion 10% (human) with recombinant human hyaluronidase) Treatment of chronic inflammatory demyelinating polyneuropathy 03/31/2016 Designated
2743 Immune globulin intravenous (human) Treatment of polymyositis/dermatomyositis. 10/13/1992 Designated/Withdrawn
2744 Immune globulin intravenous (human) Treatment of juvenile rheumatoid arthritis. 12/16/1992 Designated/Withdrawn
2745 Immune globulin intravenous (human) Treatment of patients with acute myocarditis. 11/22/1993 Designated/Withdrawn
2746 Immune Globulin Intravenous (Human) Treatment of systemic sclerosis 01/28/2020 Designated
2747 Immune Globulin Intravenous (human) Treatment for Guillain Barre Syndrome 05/04/2004 Designated
2748 immune globulin intravenous (human) Treatment of idiopathic thrombocytopenic purpura (also known as primary immune thrombocytopenia) 04/29/2011 Designated/Approved
2749 Immune globulin intravenous (human) octagam 10% Treatment of dermatomyositis 04/19/2017 Designated
2750 Immune globulin intravenous, human Infection prophylaxis in pediatric patients affected with the human immunodeficiency virus. 02/18/1993 Designated/Approved
2751 Immune Globulin Subcutaneous (Human) Treatment of patients with primary immune deficiency (PID) that are intolerant to immune globulin intravenous (IGIV) due to severe adverse events or poor venous access 09/22/2004 Designated/Withdrawn
2752 immune globulin subcutaneous (Human) Treatment of Dermatomyositis 09/12/2018 Designated
2753 Immune Globulin Subcutaneous (Human), 20% Liquid Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) 08/18/2014 Designated/Approved
2754 immunoglobulin G degrading enzyme of Streptococcus pyogenes Prevention of antibody mediated organ rejection in solid organ transplant patients. 09/10/2015 Designated
2755 immunologically active synthetic peptides Treatment of Hemophilia A 06/01/2015 Designated
2756 Immunotherapeutic vaccine consisting of (PAM)2-Lys-Ser-Ser-Gln-Tyr-Ile-Lys-Ala-Asn-Ser-Lys-Phe-Ile-Gly-Ile-Thr-Glu-Ala-Ala-Ala-Phe-Leu-Pro-Ser-Asp-Phe-Phe-Pro-Ser-Val Treatment of chronic active hepatitis B infection in HLA-A2 positive patients. 03/16/1994 Designated
2757 Implitapide Treatment of patients with Fredrickson type I or V hyperlipoproteinemia 08/19/2004 Designated/Withdrawn
2758 Implitapide Treatment of homozygous familial hypercholesterolemia 08/13/2004 Designated/Withdrawn
2759 Imported fire ant venom, allergenic extract For skin testing of victims of fire ant stings to confirm fire ant sensitivity and if positive, for use as immunotherapy for the prevention of IgE-mediated anaphylactic reactions. 05/12/1992 Designated
2760 Inactivated purified rabies virus (IPRV) and the PIKA adjuvant (Poly I:C, kanamycin and calcium) Prevention of rabies virus infection including post-exposure prophylaxis (PEP) for rabies 12/29/2016 Designated
2761 Inactivated purified rabies virus (IPRV) and the PIKA adjuvant (Polyinosinic-polycyidylic acid, kanamycin and calcium) Treatment of Pancreatic Cancer 02/15/2018 Designated
2762 Inalimarev and falimarev Treatment of adenocarcinoma of the pancreas 01/10/2006 Designated
2763 inBreath airway transplant system To restore the structure and/or function of the trachea subsequent to tracheal damage due to cancer, injury or infection 09/04/2014 Designated
2764 inclisiran Treatment of homozygous familial hypercholesterolemia (HoFH) 01/22/2018 Designated
2765 Indium In 111 murine monoclonal antibody FAB to myosin To aid in the diagnosis of myocarditis. 08/07/1989 Designated/Withdrawn
2766 Indium In-111 altumomab pentetate Detection of suspected and previously unidentified tumor foci of recurrent colorectal carcinoma. 02/06/1990 Designated/Withdrawn
2767 Indium-111 pentetreotide Treatment of neuroendocrine tumors 06/16/2006 Designated
2768 Indolino-benzodiazepine compound (sulfonated DGN462) conjugated to the humanized anti-CD33 monoclonal antibody (Z4681A) via the sulfo-SPDB linker Treatment of acute myeloid leukemia 05/02/2018 Designated
2769 Indolino-benzodiazepine compound (sulfonated DGN549-C) conjugated to the humanized anti-CD123 monoclonal antibody (G4723A) Treatment of acute myeloid leukemia 10/10/2018 Designated
2770 indoximod Treatment of Stage IIB to IV melanoma 10/26/2017 Designated
2771 indralin Prevention of acute radiation syndrome (ARS) 06/13/2018 Designated
2772 inebilizumab Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders 02/10/2016 Designated/Approved
2773 inebilizumab Treatment of scleroderma 12/03/2009 Designated
2774 Inecalcitol Treatment of chronic lymphocytic leukemia 05/14/2014 Designated/Withdrawn
2775 inecalcitol Treatment of acute myeloid leukemia. 08/03/2015 Designated/Withdrawn
2776 Infigratinib Treatment of cholangiocarcinoma 09/11/2019 Designated
2777 infliximab Treatment of pediatric (0 to 16 years of age) ulcerative colitis 11/12/2003 Designated/Approved
2778 Infliximab Treatment of pediatric (0 to 16 years of age) Crohn's Disease 11/12/2003 Designated/Approved
2779 infliximab Treatment of Crohn's disease 11/14/1995 Designated/Approved
2780 infliximab Treatment of giant cell arteritis 05/06/2003 Designated/Withdrawn
2781 infliximab Treatment of juvenile rheumatoid arthritis 10/23/2002 Designated
2782 Infliximab Treatment of chronic sarcoidosis 05/21/2003 Designated
2783 inhibitor of microRNA-451 Treatment of polycythemia vera 02/04/2011 Designated/Withdrawn
2784 Inhibitor of Tissue Factor Pathway Inhibitor (TFPI) Treatment of hemophilia A and hemophilia B. 01/29/2010 Designated
2785 inolimomab Treatment of graft versus host disease 10/23/2002 Designated
2786 Inosine pranobex Treatment of subacute sclerosing panencephalitis. 09/20/1988 Designated
2787 Inotersen Treatment of transthyretin amyloidosis (ATTR amyloidosis) 07/24/2012 Designated/Approved
2788 inotuzumab ozogamicin Treatment of B-cell acute lymphoblastic leukemia 03/25/2013 Designated/Approved
2789 insecticidal toxin derived from Bacillus thuringiensis Treatment of soil transmitted helminth infection strongyloidiasis 09/05/2008 Designated
2790 Insulin producing cells (autologous liver cells transduced by Ad5-CMV-MafA, Ad5-CMV-NeuroD1, and Ad5-CMV-PDX1) Treatment of diabetes due to total pancreatectomy. 06/11/2019 Designated
2791 inter-Alpha-Inhibitor-Proteins (IaIp) (Human) Treatment of necrotizing enterocolitis (NEC) 02/13/2018 Designated
2792 Interferon alfa-2a Treatment of chronic myelogenous leukemia. 06/06/1989 Designated/Approved
2793 Interferon alfa-2a (recombinant) Treatment of renal cell carcinoma. 04/18/1988 Designated
2794 Interferon alfa-2a (recombinant) For the concomitant administration with fluorouracil for the treatment of advanced colorectal cancer. 05/14/1990 Designated
2795 Interferon alfa-2a (recombinant) For use in combination with fluorouracil for the treatment of esophageal carcinoma. 10/27/1989 Designated
2796 Interferon alfa-2a (recombinant) For the concomitant administration with Teceleukin for the treatment of metastatic renal cell carcinoma. 05/02/1990 Designated
2797 Interferon alfa-2a (recombinant) For the treatment of metastatic malignant melanoma in combination with Teceleukin. 05/11/1990 Designated
2798 Interferon alfa-2a (recombinant) Treatment of AIDS related Kaposi's sarcoma. 12/14/1987 Designated/Approved
2799 Interferon alfa-2b (recombinant) Treatment of chronic delta hepatitis. 05/04/1990 Designated/Withdrawn
2800 Interferon alfa-2b (recombinant) Treatment of laryngeal (respiratory) papillomatosis. 08/17/1988 Designated/Withdrawn
2801 Interferon alfa-2b (recombinant) Treatment of AIDS-related Kaposi's sarcoma. 06/24/1987 Designated/Approved
2802 Interferon alfa-2b (recombinant) Treatment of carcinoma in situ of the urinary bladder. 08/10/1988 Designated/Withdrawn
2803 Interferon alfa-2b (recombinant) Treatment of metastatic renal cell carcinoma. 06/22/1987 Designated/Withdrawn
2804 Interferon alfa-2b (recombinant) Treatment of primary malignant brain tumors. 05/13/1988 Designated/Withdrawn
2805 Interferon alfa-2b (recombinant) Treatment of invasive carcinoma of the cervix. 04/18/1988 Designated/Withdrawn
2806 Interferon alfa-2b (recombinant) Treatment of acute hepatitis B. 11/17/1988 Designated/Withdrawn
2807 Interferon alfa-2b (recombinant) Treatment of chronic myelogenous leukemia. 06/22/1987 Designated/Withdrawn
2808 Interferon alfa-2b (recombinant) Treatment of ovarian carcinoma. 08/03/1987 Designated/Withdrawn
2809 Interferon alfa-nl Treatment of AIDS related Kaposi's sarcoma. 08/25/1986 Designated/Withdrawn
2810 Interferon alfa-nl Treatment of human papillomavirus in patients with severe resistant/recurrent respiratory (laryngeal) papillomatosis. 10/16/1987 Designated/Withdrawn
2811 Interferon beta (recombinant human) Treatment of primary brain tumors. 01/13/1993 Designated/Withdrawn
2812 Interferon beta (recombinant) For the intralesional and/or systemic treatment of AIDS-related Kaposi's sarcoma. 05/09/1991 Designated/Withdrawn
2813 Interferon beta (recombinant) For the systemic treatment of metastatic renal cell carcinoma. 02/12/1991 Designated/Withdrawn
2814 Interferon beta (recombinant) For the systemic treatment of cutaneous T-cell lymphoma. 04/18/1991 Designated/Withdrawn
2815 Interferon beta, recombinant human Treatment of acquired immunodeficiency syndrome. 11/15/1988 Designated/Withdrawn
2816 Interferon beta-1a Treatment of patients with secondary progressive multiple sclerosis 03/11/1996 Designated/Withdrawn
2817 interferon Beta-1a Treatment of juvenile rheumatoid arthritis. 10/14/1998 Designated/Withdrawn
2818 Interferon beta-1a Treatment of multiple sclerosis. 12/16/1991 Designated/Approved
2819 Interferon beta-1a (recombinant human) Treatment of pulmonary fibrosis. 01/07/1999 Designated/Withdrawn
2820 Interferon beta-1a (recombinant human) Treatment of acute non-A, non-B hepatitis. 07/24/1992 Designated
2821 Interferon beta-1a (recombinant) For the systemic treatment of cutaneous malignant melanoma. 04/03/1991 Designated/Withdrawn
2822 Interferon beta-1a (recombinant) Treatment of symptomatic patients with AIDS including all patients with CD4 T-cell counts less than 200 cells per mm3. 12/02/1992 Designated/Withdrawn
2823 Interferon beta-1b Treatment of multiple sclerosis. 11/17/1988 Designated/Approved
2824 Interferon gamma Treatment of idiopathic pulmonary fibrosis 10/11/2007 Designated
2825 interferon gamma Treatment of Friedreich's ataxia 11/04/2011 Designated
2826 Interferon gamma 1-b Treatment of chronic granulomatous disease. 09/30/1988 Designated/Approved
2827 interferon gamma-1b Treatment of idiopathic pulmonary fibrosis 09/12/2002 Designated/Withdrawn
2828 Interferon gamma-1b Delaying time to disease progression in patients with severe, malignant osteopetrosis. 09/30/1996 Designated/Approved
2829 interferon gamma-1b Treatment of Friedreich's Ataxia 10/01/2014 Designated
2830 Interferon gamma-1b Treatment of renal cell carcinoma. 12/04/1995 Designated
2831 Interferon-alfa-1b Treatment of multiple myeloma 04/17/2001 Designated
2832 interferon-alpha secreting autologous micro-organ tissue converting into a biopump Treatment of chronic hepatitis D 06/14/2012 Designated
2833 interleukin mutein fused to the C-terminus of an immunoglobulin G Fc domain by way of a G4S linker Treatment of Graft-Versus-Host-Disease 03/23/2020 Designated
2834 Interleukin-1 alpha, human recombinant For hematopoietic potentiation in aplastic anemia. 06/17/1991 Designated/Withdrawn
2835 Interleukin-1 alpha, human recombinant For the promotion of early engraftment in bone marrow transplantation. 06/17/1991 Designated/Withdrawn
2836 interleukin-1 receptor antagonist (IL-1Ra, sequence-homologous anakinra) Treatment of Bronchiolitis Obliterans 08/07/2018 Designated
2837 interleukin-1 receptor antagonist anakinra Treatment of Still's disease including systemic juvenile idiopathic arithritis and adult-onset Still's disease. 09/15/2015 Designated
2838 Interleukin-1 receptor antagonist, human recombinant Treatment of juvenile rheumatoid arthritis. 09/23/1991 Designated
2839 Interleukin-1 receptor antagonist, human recombinant Prevention and treatment of graft versus host disease in transplant recipients. 10/16/1992 Designated
2840 Interleukin-1 Trap Treatment of Still's disease including juvenile rheumatoid arthritis and adult-onset Still's disease 04/04/2005 Designated
2841 Interleukin-2 In combination with interferon alfa-2a for the treatment of metastatic renal cell carcinoma. 05/03/1990 Designated
2842 Interleukin-2 In combination with interferon alfa-2a for the treatment of metastatic malignant melanoma. 05/11/1990 Designated
2843 Interleukin-2 Treatment of metastatic malignant melanoma. 02/06/1990 Designated
2844 Interleukin-2 Treatment of metastatic renal cell carcinoma. 02/05/1990 Designated
2845 Interleukin-3 human (recombinant) Promotion of erythropoiesis in Diamond-Blackfan anemia (congenital pure red cell aplasia). 05/20/1991 Designated/Withdrawn
2846 Interleukin-3, human, recombinant For sequential administration with sargramostim to accelerate neutrophil and platelet recovery in patients undergoing autologous bone marrow transplantation for the treatment of Hodgkin's disease or non-Hodgkin's lymphoma. 09/30/1993 Designated/Withdrawn
2847 internalized-arginylglycylaspartic acid cyclic peptide Treatment of pancreatic cancer 01/29/2019 Designated
2848 Intraoral fluoride releasing system Prevention of dental caries due to radiation-induced xerostomia in patients with head and neck cancer 07/31/2001 Designated
2849 intravenous baclofen Prevention of baclofen withdrawal syndrome 04/20/2020 Designated
2850 intravenous carbamazepine Treatment of epilepsy patients who cannot take anything by mouth (NPO) 06/27/2013 Designated/Approved
2851 Intravenous immune globulin Treatment of Stage IIB to IV malignant melanoma 07/26/2007 Designated
2852 Intravenous immune globulin (human) 10% Treatment of stiff-person syndrome 07/31/2008 Designated
2853 intraventricular nimodipine Treatment of subarachnoid hemorrhage 05/28/2015 Designated
2854 Iobenguane I 123 For the diagnosis of neuroblastomas 12/01/2006 Designated/Approved
2855 Iobenguane I 123 For the diagnosis of pheochromocytomas 12/01/2006 Designated/Approved
2856 iobenguane I 131 Treatment of neuroendocrine tumors 07/05/2007 Designated
2857 Iobenguane I 131 Treatment of neuroendocrine tumors 01/18/2006 Designated/Approved
2858 Iobenguane Sulfate I 131 For use as a diagnostic adjunct in patients with pheochromocytoma. 11/14/1984 Designated/Approved/Withdrawn
2859 iobenguane sulfate I-123 For the detection, localization, and staging of pheochromocytomas. 10/21/2005 Designated
2860 Iobenguane Sulfate I-123 For scintigraphic detection, localization and staging of neuroblastoma. 10/17/2005 Designated
2861 Iodine 131 6B-iodomethyl-19-norcholesterol For use in adrenal cortical imaging. 08/01/1984 Designated
2862 Iodine I 123 murine monoclonal antibody to alpha-fetoprotein 1. Detection of hepatocellular carcinoma and hepatoblastoma 2. Detection of alpha-fetoprotein producing germ cell tumors 09/30/1988 Designated/Withdrawn
2863 Iodine I 123 murine monoclonal antibody to hCG Detection of hCG producing tumors such as germ cell and trophoblastic cell tumors. 11/07/1988 Designated
2864 Iodine I 131 bis(indium-diethylenetriaminepentaacetic acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific monoclonal antibody Treatment of small-cell lung cancer. 02/22/2000 Designated
2865 Iodine I 131 Lym-1 Monoclonal Antibody Treatment of B-cell lymphoma. 11/02/1987 Designated/Withdrawn
2866 Iodine I 131 murine monoclonal antibody IgG2a to B cell Treatment of B-cell leukemia and B-cell lymphoma. 09/18/1989 Designated/Withdrawn
2867 Iodine I 131 murine monoclonal antibody to alpha-fetoprotein 1. Treatment of hepatocellular carcinoma and hepatoblastoma 2. Treatment of alpha-fetoprotein producing germ cell tumors 09/30/1988 Designated/Withdrawn
2868 Iodine I 131 murine monoclonal antibody to hCG Treatment of hCG producing tumors such as germ cell and trophoblastic cell tumors. 11/07/1988 Designated/Withdrawn
2869 Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B) Treatment of glioblastoma multiforme and anaplastic astrocytoma. 02/12/1999 Designated
2870 Ipatasertib For the treatment of gastric cancer including cancer of the gastro-esophageal junction. 04/30/2014 Designated/Withdrawn
2871 ipilimumab Treatment of high risk Stage II, Stage III, and Stage IV melanoma 06/03/2004 Designated/Approved
2872 ipilimumab Treatment of high risk Stage II, Stage III, and Stage IV melanoma 06/03/2004 Designated/Approved
2873 ipilimumab Treatment of high risk Stage II, Stage III, and Stage IV melanoma 06/03/2004 Designated/Approved
2874 ipilimumab Treatment of small cell lung cancer 11/07/2018 Designated
2875 irinotecan liposome injection Treatment of small cell lung cancer 05/24/2017 Designated
2876 irinotecan liposome injection Treatment of pancreatic cancer 07/21/2011 Designated/Approved
2877 irofulven Treatment of renal cell carcinoma. 07/27/1999 Designated/Withdrawn
2878 irofulven Treatment of ovarian cancer. 07/06/1999 Designated/Withdrawn
2879 iron(III)-hexacyanoferrate(II) Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium 05/01/2003 Designated/Approved
2880 isatuximab Treatment of multiple myeloma 05/22/2014 Designated/Approved
2881 isavuconazonium sulfate Treatment of invasive aspergillosis 05/06/2013 Designated/Approved
2882 isavuconazonium sulfate Treatment of zygomycosis 10/25/2013 Designated/Approved
2883 isavuconazonium sulfate Treatment of invasive candidiasis/candidemia 10/20/2014 Designated
2884 Isobutyramide Treatment of sickle cell disease and beta thalassemia. 05/25/1994 Designated
2885 Isobutyramide Treatment of beta-hemoglobinopathies and beta-thalassemia syndromes. 12/18/1992 Designated
2886 isofagomine tartrate Treatment of Gaucher disease 01/10/2006 Designated/Withdrawn
2887 Isoindolin-1,3-Di Thione Treatment of Frontotemporal dementia 11/21/2016 Designated
2888 isotretinoin Treatment of congenital ichthyosis 04/10/2014 Designated
2889 Istiratumab Treatment of pancreatic cancer 10/22/2014 Designated
2890 itacitinib Treatment of graft versus host disease 04/17/2017 Designated
2891 itolizumab Prevention of acute graft versus host disease 02/05/2019 Designated
2892 itolizumab Treatment of acute graft versus host disease 02/01/2019 Designated
2893 Itraconazole Treatment of basal cell carcinoma nevus syndrome. 05/19/2016 Designated
2894 itraconazole inhalation powder Treatment of pulmonary fungal infections in patients with cystic fibrosis 08/16/2016 Designated
2895 Itraconazole suspension Topical treatment of fungal otitis externa (otomycosis) 10/30/2008 Designated
2896 ivabradine Treatment of pediatric patients (0 through 16 years of age) with dilated cardiomyopathy. 03/23/2016 Designated/Approved
2897 ivabradine Treatment of post-cardiac transplant heart dysfunction 07/09/2018 Designated/Withdrawn
2898 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2899 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2900 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2901 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2902 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2903 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2904 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2905 ivacaftor Treatment of patients with cystic fibrosis 12/20/2006 Designated/Approved
2906 ivosidenib Treatment of glioma. 05/01/2018 Designated
2907 ivosidenib Treatment of acute myeloid leukemia (AML) 06/09/2015 Designated/Approved
2908 ivosidenib Treatment of acute myeloid leukemia (AML) 06/09/2015 Designated/Approved
2909 ivosidenib Treatment of myelodysplastic syndromes 05/20/2020 Designated
2910 ivosidenib Treatment of cholangiocarcinoma 04/26/2017 Designated
2911 ixazomib citrate Treatment of multiple myeloma 02/18/2011 Designated/Approved
2912 ixmyelocel-T Treatment of dilated cardiomyopathy 01/25/2007 Designated
2913 Japanese encephalitis vaccine (live, attenuated) Prevention of Japanese encephalitis. 05/19/1999 Designated
2914 Japanese encephalitis vaccine, inactivated, adsorbed Prevention of Japanese encephalitis virus in pediatric patients. 09/25/2012 Designated/Approved
2915 Kallikrein 7 and elastase 2 inhibitor Treatment of Netherton Syndrome 06/25/2019 Designated
2916 ketamine Treatment of Complex Regional Pain Syndrome 02/01/2019 Designated
2917 Ketoconazole For use with cyclosporine A to diminish the nephrotoxicity induced by cyclosporine in organ transplantation. 03/27/1991 Designated/Withdrawn
2918 ketotifen Treatment of mastocytosis 02/25/2015 Designated
2919 KIT and PDGFR inhibitor Treatment of glioblastoma multiforme and anaplastic astrocytomas 08/07/2017 Designated
2920 Kre-Celazine Treatment of juvenile rheumatoid arthritis joint and related tissue inflammation in the pediatric population 04/01/2013 Designated
2921 L-2-oxothiazolidine-4-carboxylic acid Treatment of amyotrophic lateral sclerosis. 07/30/1996 Designated
2922 L-2-oxothiazolidine-4-carboxylic acid Treatment of adult respiratory distress syndrome. 06/14/1994 Designated
2923 L-3,4-Dihydroxy-6-18Ffluorophenylalanine Diagnostic agent for the management of patients with aromatic L-amino acid decarboxylase deficiency (AADC). 05/31/2017 Designated
2924 L-5 Hydroxytrytophan Treatment of postanoxic intention myoclonus. 11/01/1984 Designated
2925 L-5-hydroxytryptophan Treatment of tetrahydrobiopterin deficiency. 01/20/1999 Designated
2926 L-alanoyl-D-glutamate endopeptidase from Bacillus-infected bacteriophages Treatment of inhalational anthrax 06/21/2018 Designated
2927 L-amino acids, vitamins and minerals combined with omega-3 fatty acids Treatment of patients with pediatric Crohn's disease 01/12/2011 Designated
2928 L-aminocarnityl-succinyl-leucyl-argininal-diethylacetal Treatment of Duchenne and Becker muscular dystrophy 01/18/2006 Designated
2929 L-arginyl-L-isoleucyl-L-valyl-L-prolyl-L-alanine-amide Treatment of acute radiation syndrome 09/11/2013 Designated
2930 L-asparaginase Treatment of acute myeloid leukemia 03/27/2014 Designated
2931 L-asparaginase encapsulated in red blood cells Treatment of pancreatic cancer. 07/06/2012 Designated
2932 L-asparaginase encapsulated in red blood cells Treatment of acute lymphoblastic leukemia 01/06/2010 Designated
2933 L-baclofen Treatment of trigeminal neuralgia 01/06/1998 Designated
2934 L-baclofen Treatment of trigeminal neuralgia. 07/13/1990 Designated
2935 L-baclofen Treatment of intractable spasticity in children with cerebral palsy. 01/30/1992 Designated
2936 L-baclofen Treatment of spasticity associated with spinal cord injury or multiple sclerosis. 12/17/1991 Designated
2937 L-citrulline Prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric patients 01/09/2017 Designated
2938 L-cycloserine Treatment of Gaucher's disease. 08/01/1989 Designated
2939 L-cysteine For the prevention and lessening of photosensitivity in erythropoietic protoporphyria. 05/16/1994 Designated
2940 L-cystine bis(N'-methylpiperazide) Treatment of cystinuria. 06/04/2018 Designated
2941 L-fucose Treatment of Congenital Disorder of Glycosylation IIc 01/14/2019 Designated
2942 L-fucose Treatment of Leukocyte Adhesion Deficiency Type- II 06/08/2020 Designated
2943 L-glutamine Treatment of sickle cell disease 08/01/2001 Designated/Approved
2944 L-glutamyl-L-tryptophan Treatment of AIDS-related Kaposi's sarcoma. 10/20/1999 Designated
2945 L-Leucyl-L-prolyl-L-prolyl-L-leucyl-L-prolyl-L-tyrosyl-L-proline, acetate salt Treatment of Amyotrophic Lateral Sclerosis 06/19/2019 Designated
2946 L-Lysinamide,N2,N6-bis(L-lysylglycyl-L-valyl-L-seryl-L-leucyl-L-seryl-L-tyrosyl-L-arginyl)-hexa-acetate salt Treatment of hepatocellular carcinoma 09/18/2019 Designated
2947 L-ornithine phenylacetate Treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure or acute on chronic liver disase 04/07/2010 Designated
2948 L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser Treatment to increase survival and improve functioning of pancreatic islets following transplantation 06/13/2016 Designated
2949 L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser Treatment of neuropathic pain in patients with sarcoidosis. 09/13/2011 Designated
2950 L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser Prevention of delayed graft function following renal transplant 09/18/2009 Designated
2951 L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser Treatment of sarcoidosis. 06/13/2016 Designated
2952 L-serine, L-threonine, L-leucine, glycine, L-alanine, L-arginine, L-cysteine, L-glutamine, L-histidine, L-aspartic acid, L-proline, L-isoleucine, L-lysine, L-tryptophan, L-valine, L-methionine, L-tyrosine, carnitine and taurine Treatment of phenylketonuria 03/23/2020 Designated
2953 L-threonine Treatment of amyotrophic lateral sclerosis. 02/06/1989 Designated/Withdrawn
2954 L-threonine Treatment of spasticity associated with familial spastic paraparesis. 07/24/1992 Designated/Withdrawn
2955 L-threonyl-L-prolyl-L-prolyl-L-threonine Treatment of neuropathic pain associated with spinal cord injury 04/26/2005 Designated
2956 L-tyrosine-L-serine-L-leucine Treatment of hepatocellular carcinoma. 09/10/2004 Designated
2957 L. reuteri Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams 08/01/2013 Designated
2958 Lacnotuzumab Treatment of pigmented villonodular synovitis, including giant cell tumor of the tendon sheath 08/19/2014 Designated
2959 Lactic acid Treatment of severe aphthous stomatitis in severely, terminally immunocompromised patients. 06/29/1999 Designated
2960 lactic acid bacteria (Lactobacilli, Bifidobacteria, and Steptococci) Treatment of active chronic pouchitis 01/15/2002 Designated
2961 lactic acid bacteria (Lactobacilli, Bifidobacteria, and Streptococcus species) Prevention of disease relapse in patients with chronic pouchitis 01/15/2002 Designated
2962 Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis Prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1500 grams 03/24/2015 Designated
2963 lactobacillus brevis CD2 Treatment Behcet's disease 10/04/2011 Designated
2964 lactobacillus plantarum Treatment of amyotrophic lateral sclerosis (ALS) 11/30/2016 Designated
2965 Lactobin Treatment of AIDS-associated diarrhea unresponsive to initial antidiarrheal therapy. 09/12/1990 Designated/Withdrawn
2966 laminin-111 (human) Treatment of Duchenne Muscular Dystrophy 07/21/2011 Designated
2967 Lamotrigine Treatment of Lennox-Gastaut syndrome. 08/23/1995 Designated/Approved
2968 lanadelumab-flyo Treatment of angioedema 11/26/2013 Designated/Approved
2969 Lanreotide Treatment for acromegly 09/11/2000 Designated/Approved
2970 lanreotide acetate Treatment of neuroendocrine tumors 08/25/2011 Designated/Approved
2971 lanreotide acetate Treatment of carcinoid syndrome 09/08/2011 Designated/Approved
2972 lapatinib Treatment of ErbB2 positive gastric cancer 05/29/2009 Designated/Withdrawn
2973 lapatinib ditosylate hydrochloride Treatment of ErbB2 positive esophageal cancer 05/29/2009 Designated/Withdrawn
2974 laquinimod sodium Treatment of Huntington's Disease 01/31/2017 Designated
2975 laromustine Treatment of acute myelogenous leukemia 10/21/2004 Designated
2976 Laromustine Treatment of acute myelogenous leukemia 03/27/2014 Designated
2977 laronidase Treatment of patients with mucopolysaccharidosis-I. 09/24/1997 Designated/Approved
2978 Larotrectinib Treatment of soft tissue sarcoma. 08/31/2015 Designated
2979 larotrectinib Treatment of solid tumors with NTRK-fusion proteins 05/09/2017 Designated/Approved
2980 late stage human motor neutron progenitors Treatment of spinal muscular atrophy 11/25/2009 Designated/Withdrawn
2981 Latrodectus immune F(ab)2 Treatment of black widow spider envenomations 06/18/2001 Designated
2982 Lead-212 DOTAMTATE Treatment of neuroendocrine tumors 10/11/2018 Designated
2983 lebrikizumab Treatment of idiopathic pulmonary fibrosis 03/09/2015 Designated
2984 ledipasvir/sofosbuvir Treatment of chronic hepatitis C virus (HCV) infection in pediatric patients 10/12/2016 Designated/Approved
2985 ledipasvir/sofosbuvir Treatment of chronic hepatitis C virus (HCV) infection in pediatric patients 10/12/2016 Designated/Approved
2986 ledipasvir/sofosbuvir Treatment of chronic hepatitis C virus (HCV) infection in pediatric patients 10/12/2016 Designated/Approved
2987 Leflunomide Prevention of acute and chronic rejection in patients who have received solid organ transplants. 10/18/1996 Designated
2988 lenabasum Treatment of dermatomyositis 07/18/2018 Designated
2989 lenadogene nolparvovec Treatment of Leber Hereditary Optic Neuropathy 11/20/2013 Designated
2990 lenalidomide Treatment of multiple myeloma 09/20/2001 Designated/Approved
2991 lenalidomide Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue 04/29/2015 Designated/Approved
2992 lenalidomide Treatment of mantle cell lymphoma 04/27/2009 Designated/Approved
2993 lenalidomide Treatment of multiple myeloma 09/20/2001 Designated/Approved
2994 lenalidomide Treatment of follicular lymphoma 09/17/2013 Designated/Approved
2995 lenalidomide Treatment of diffuse large B-cell lymphoma 03/28/2011 Designated
2996 lenalidomide Treatment of nodal marginal zone lymphoma 01/04/2017 Designated/Approved
2997 lenalidomide Treatment of splenic marginal zone lymphoma 01/04/2017 Designated/Approved
2998 lenalidomide Treatment of chronic lymphocytic leukemia 01/17/2007 Designated/Withdrawn
2999 lenalidomide Treatment of myelodysplastic syndromes 01/29/2004 Designated/Approved
3000 lenalidomide Treatment of multiple myeloma 09/20/2001 Designated/Approved
3001 leniolisib Treatment of activated P13Kdelta Syndrome/p110delta-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency 01/30/2018 Designated
3002 lentiviral transfected chimeric antigen receptor T-cells modified to target B-cell maturation antigen and CS1 Treatment of multiple myeloma 12/14/2017 Designated
3003 lentiviral vector containing the human ABCA4 gene Treatment of Stargardt disease 04/30/2010 Designated
3004 lentiviral vector containing the human liver and erythroid pyruvate kinase gene Treatment of pyruvate kinase deficiency. 03/23/2016 Designated
3005 lentiviral vector containing the human MY07A gene Treatment of retinitis pigmentosa associated with Usher syndrome 1B gene defect. 05/17/2010 Designated
3006 Lentiviral vector encoded with a human beta-globin gene plasmid Treatment of beta-thalassemia major and beta-thalassemia intermedia 01/11/2006 Designated
3007 Lentiviral vector expressing human fumarylacetoacetate hydrolase Treatment of hereditary tyrosinemia type I 08/08/2019 Designated
3008 lenvatinib Treatment of hepatocellular carcinoma 03/27/2014 Designated/Approved
3009 lenvatinib Treatment of follicullar, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer 12/27/2012 Designated/Approved
3010 lenvatinib Treatment of stage IIB to Stage IV melanoma 03/26/2014 Designated
3011 lenzumestrocel Treatment of amyotrophic lateral sclerosis 08/01/2018 Designated
3012 Lepirudin Treatment of heparin-associated thrombocytopenia type II. 02/13/1997 Designated/Approved
3013 leriglitazone Treatment of Friedreich´s ataxia 08/01/2019 Designated
3014 lestaurtinib Treatment of Philadelphia-negative classic myeloproliferative disorders 09/03/2009 Designated
3015 lestaurtinib Treatment of acute myeloid leukemia 03/24/2006 Designated
3016 letermovir Prevention of human cytomegalovirus viremia and disease in at risk populations 12/12/2011 Designated/Approved
3017 Leu-Lys-Gly-Gln-Leu-Arg-Cys-Ile Treatment of pancreatic cancer 08/07/2017 Designated
3018 Leucovorin For use in combination with 5-fluorouracil for the treatment of metastatic colorectal cancer. 12/08/1986 Designated/Approved
3019 Leucovorin For rescue use after high dose methotrexate therapy in the treatment of osteosarcoma. 08/17/1988 Designated/Approved
3020 Leucovorin calcium For use in combination with 5-fluorouracil for the treatment of metastatic colorectal cancer. 06/23/1988 Designated/Withdrawn
3021 leukocyte interleukin Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck 05/04/2007 Designated
3022 leukotriene A4 hydrolase inhibitor Treatment of cystic fibrosis 01/26/2015 Designated
3023 Leupeptin For use as an adjunct to microsurgical peripheral nerve repair. 09/18/1990 Designated
3024 Leuprolide acetate Treatment of central precocious puberty 07/25/1988 Designated/Approved
3025 levetiracetam Treatment of neonatal seizures 04/30/2010 Designated
3026 Levocabastine HCl ophthalmic suspension 0.05% Treatment of vernal keratoconjunctivitis. 02/29/1988 Designated/Withdrawn
3027 Levocarnitine Treatment of primary and secondary carnitine deficiency of genetic origin. 07/26/1984 Designated/Approved
3028 Levocarnitine Treatment of zidovudine-induced mitochondrial myopathy. 04/07/1997 Designated
3029 Levocarnitine Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis. 11/24/1986 Designated/Withdrawn
3030 Levocarnitine Treatment of genetic carnitine deficiency. 02/28/1984 Designated/Approved
3031 levocarnitine 1. Prevention of secondary carnitine deficiency in valproic acid toxicity 2. Treatment of secondary carnitine deficiency in valproic acid toxicity 11/15/1989 Designated
3032 Levocarnitine Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis. 09/06/1988 Designated/Approved
3033 Levocarnitine Treatment of pediatric cardiomyopathy. 11/22/1993 Designated
3034 levodopa and carbidopa Treatment of late stage Parkinson's disease 01/18/2000 Designated/Approved
3035 Levofloxacin Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis patients 02/27/2008 Designated
3036 levoleucovorin For use in combination chemotherapy with the approved agent 5-fluorouracil in the palliative treatment of metastatic adenocarcinoma of the colon and rectum 12/18/1990 Designated/Approved
3037 Levoleucovorin For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma. 08/01/1991 Designated/Approved
3038 levomefolate calcium Treatment of megaloblastic anemia caused by folate deficiency 02/10/2015 Designated
3039 Levomethadyl acetate hydrochloride Treatment of heroin addicts suitable for maintenance on opiate agonists. 01/24/1985 Designated/Approved
3040 levosimendan Treatment of amyotrophic lateral sclerosis 04/10/2017 Designated
3041 levothyroxine sodium The preservation of organ function in brain-dead organ donors. 04/26/2011 Designated
3042 liarozole Treatment of congenital ichthyosis 06/18/2004 Designated/Withdrawn
3043 Lidocaine patch 5% For relief of allodynia (painful hypersensitivity), and chronic pain in postherpetic neuralgia. 10/24/1995 Designated/Approved
3044 linerixibat Treatment of Primary Biliary Cholangitis 09/18/2019 Designated
3045 linsitinib Treatment of adrenocortical carcinoma 03/09/2012 Designated/Withdrawn
3046 lintuzumab Treatment of acute myeloid leukemia. 01/30/2007 Designated/Withdrawn
3047 lintuzumab Treatment of myelodysplastic syndrome 03/20/2007 Designated/Withdrawn
3048 lintuzumab Treatment of acute myelogenous leukemia 09/09/2002 Designated/Withdrawn
3049 Liothyronine sodium injection Treatment of myxedema coma/precoma. 07/30/1990 Designated/Approved
3050 lipase, amylase, and protease Treatment of pancreatic insufficiency 01/23/2002 Designated/Withdrawn
3051 Lipid/DNA human cystic fibrosis gene Treatment of cystic fibrosis. 04/08/1996 Designated/Withdrawn
3052 liposomal amikacin Treatment of bronchiectasis in patients with Pseudomonas aeruginosa or other susceptible microbial pathogens 08/25/2009 Designated
3053 liposomal amikacin Treatment of bronchopulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients 03/09/2006 Designated
3054 liposomal amikacin Treatment of infections caused by non-tuberculous mycobacteria 03/25/2013 Designated/Approved
3055 Liposomal amphotericin B Treatment of cryptococcal meningitis. 12/10/1996 Designated/Approved
3056 Liposomal amphotericin B Treatment of visceral leishmaniasis. 12/06/1996 Designated/Approved
3057 Liposomal amphotericin B Treatment of histoplasmosis. 12/10/1996 Designated
3058 Liposomal annamycin Treatment of acute lymphoblastic leukemia 06/17/2005 Designated
3059 liposomal annamycin Treatment of acute myeloid leukemia. 03/20/2017 Designated
3060 Liposomal annamycin Treatment of acute myeloid leukemia 06/17/2005 Designated
3061 liposomal busulfan For use as a conditioning regimen for patients with malignancies undergoing autologous or allogeneic hematopoietic stem cell transplantation 06/24/2013 Designated
3062 Liposomal ciprofloxacin for inhalation Management of bronchiectasis 12/27/2006 Designated
3063 liposomal ciprofloxacin for inhalation Management of cystic fibrosis 04/19/2006 Designated
3064 liposomal ciprofloxacin plus ciprofloxacin For the management of cystic fibrosis 06/01/2012 Designated
3065 Liposomal cisplatin Treatment of ovarian cancer 05/23/2006 Designated
3066 Liposomal cyclosporin A For aerosolized administration in the prevention and treatment of lung allograft rejection and pulmonary rejection events associated with bone marrow transplantation. 04/30/1998 Designated
3067 liposomal cyclosporine Treatment of bronchiolitis obliterans 05/11/2009 Designated
3068 liposomal cyclosporine for inhalation Prevention of bronchiolitis obliterans. 06/24/2008 Designated
3069 Liposomal doxorubicin hydrochloride Treatment of soft tissue sarcomas 12/27/2006 Designated
3070 liposomal encapsulated paclitaxel Treatment of ovarian cancer 01/21/2015 Designated
3071 liposomal gadodiamide Treatment of glioma 11/12/2008 Designated
3072 liposomal glutathione Treatment of Dengue Virus infection. 05/18/2016 Designated
3073 Liposomal Glutathione Support of glutathione deficiency in individuals with inborn errors of metabolism of glutathione (IEMG) 04/30/2010 Designated
3074 liposomal mannose-1-phosphate Treatment of Phosphomannomutase 2-Congenital Disorder of Glycosylation 06/04/2018 Designated
3075 Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl Treatment of osteosarcoma. 06/10/1998 Designated
3076 Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl Treatment of Ewing's sarcoma. 06/10/1998 Designated
3077 Liposomal nystatin Treatment of invasive fungal infections. 06/13/2000 Designated
3078 liposomal oxaliplatin Treatment of cholangiocarcinoma 03/30/2017 Designated
3079 liposomal oxaliplatin Treatment of pancreatic adenocarcinoma 09/18/2017 Designated
3080 liposomal P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide Treatment of acute myeloid leukemia 04/27/2015 Designated
3081 liposomal p-ethoxy growth receptor bound protein-2 antisense product Treatment of chronic myelogenous leukemia 12/05/2003 Designated
3082 Liposomal prostaglandin E1 injection Treatment of acute respiratory distress syndrome. 04/25/1996 Designated/Withdrawn
3083 liposomal topotecan hydrochloride Treatment of gliomas 10/30/2008 Designated
3084 liposomal vinorelbine Treatment of soft tissue carcinoma 07/13/2017 Designated
3085 liposomal vinorelbine Treatment of cutaneous t-cell lymphoma (CTCL) 10/12/2016 Designated
3086 [[liposomal Ã}±-galactosylceramide]] Prevention of graft-versus-host disease 09/28/2012 Designated
3087 Liposomal-cis-bis-neodecanoato-trans-R,R-1,2-diaminocyclohexane-Pt (II) Treatment of malignant mesothelioma. 09/01/1999 Designated/Withdrawn
3088 liposome encapsulated paclitaxel Treatment of gastric cancer 12/03/2014 Designated
3089 Liposome encapsulated recombinant interleukin-2 Treatment of brain and CNS tumors. 11/25/1991 Designated
3090 Liposome encapsulated recombinant interleukin-2 Treatment of cancers of the kidney and renal pelvis 06/20/1994 Designated
3091 lisinopril oral solution Treatment of hypertension in pediatric patients 0 through 16 years of age. 10/14/2015 Designated/Withdrawn
3092 lisinopril oral solution Treatment of primary hypertension with complications and secondary hypertension in pediatric patients (ages 0 through 16 years of age) 01/27/2015 Designated/Withdrawn
3093 lisocabtagene maraleucel Treatment of follicular lymphoma (FL) 09/07/2017 Designated
3094 lisocabtagene maraleucel Treatment of mantle cell lymphoma 04/01/2020 Designated
3095 lisocabtagene maraleucel Treatment of diffuse large B-cell lymphoma 04/27/2016 Designated
3096 lisocabtagene maraleucel Treatment of primary mediastinal large B-cell lymphoma 07/12/2018 Designated
3097 Lisofylline Treatment of patients undergoing induction therapy for acute myeloid leukemia. 06/10/1999 Designated
3098 listeria monocytogenes Treatment of pancreatic cancer 09/05/2013 Designated/Withdrawn
3099 lisuride Treatment of pulmonary arterial hypertension 01/17/2013 Designated
3100 lithium citrate tetrahydrate (in reverse micelle formulation) Treatment of Huntington's disease. 12/13/2010 Designated
3101 live attenuated bioengineered Listeria monocytogenes immunotherapy Treatment of human papilloma virus-associated head and neck cancer 11/04/2013 Designated
3102 live attenuated bioengineered Listeria monocytogenes immunotherapy Treatment of osteosarcoma. 05/21/2014 Designated
3103 live attenuated E. Coli expressing Beta catenin shRNA Treatment of Familial Adenomatous Polyposis 12/20/2010 Designated
3104 live bacterial product consisting of defined consortia of Clostridium clusters live bacterial product consisting of defined consortia of Clostridium clusters Prevention of recurrent Clostridium difficile infection in individuals with prior recurrent Clostridium difficile infection 11/02/2017 Designated
3105 live E. coli Nissle bacterium modified to assimilate ammonia Treatment of urea cycle disorders 08/22/2016 Designated
3106 Live-attenuated Listeria monocytogenes actA/inlB/human mesothelin (hMeso) Strain hMeso38 Treatment of mesothelioma. 03/24/2015 Designated/Withdrawn
3107 lixivaptan Treatment of autosomal dominant polycystic kidney disease (ADPKD) 09/18/2017 Designated
3108 LOAd703, a modified adenovirus 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand (TMZ-CD40L) and full length 4-1BBL Treatment of pancreatic cancer 05/04/2015 Designated
3109 Lodoxamide tromethamine Treatment of vernal keratoconjunctivitis. 10/16/1991 Designated/Approved
3110 lomitapide Treatment of homozygous familial hypercholesterolemia 10/23/2007 Designated/Approved
3111 lomitapide Treatment of Familial Chylomicronemia 03/03/2011 Designated
3112 lonafarnib Treatment of Hepatitis Delta Virus (HDV)infection 11/19/2013 Designated
3113 lonafarnib Treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies 04/18/2011 Designated
3114 lonapegsomatropin Treatment of growth hormone deficiency 04/13/2020 Designated
3115 long acting recombinantFactor VIIa-CTP3 Treatment and prophylaxis of bleeding episodes in patients with hemophilia A or B with inhibitors to factor VIII or factor IX 02/27/2014 Designated
3116 lorcaserin Treatment of Dravet syndrome 04/17/2017 Designated
3117 Lorlatinib Treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer 06/23/2015 Designated/Approved
3118 losartan Treatment of Marfan Syndrome 12/12/2011 Designated
3119 Losartan Treatment of epidermolysis bullosa 01/29/2019 Designated
3120 losmapimod Treatment of Facioscapulohumeral muscular dystrophy 01/27/2020 Designated
3121 low molecular weight dextran sulfate Treatment to mobilze progenitor cells prior to stem cell transplantation 07/06/2011 Designated
3122 low molecular weight dextran sulfate Prevention of graft rejection during pancreatic islet transplantation 10/20/2009 Designated
3123 Loxoribine Treatment of common variable immunodeficiency. 02/24/1992 Designated/Withdrawn
3124 Lu-177(3+),2-5-(2,6-dimethoxyphenyl)-1-2-isopropyl-4-methyl-3-methyl-3-methyl-2-4,7,10- tris(carboxymethyl)-1,4,7,10-tetrazacyclododec-1-ylacetylaminopropylaminopropylcarbamoylphenylpyrazole-3-carbonylaminoadamantane-2-carboxylic acid Treatment of pancreatic cancer 10/28/2019 Designated
3125 lucerastat Treatment of Fabry Disease. 10/29/2015 Designated
3126 Lucinactant Treatment of respiratory distress syndrome in premature infants. 10/18/1995 Designated
3127 Lucinactant Treatment of cystic fibrosis. 10/21/2010 Designated
3128 Lucinactant Treatment of acute respiratory distress syndrome in adults. 07/17/1995 Designated
3129 Lucinactant Prevention of bronchopulmonary dysplasia in premature infants 05/23/2006 Designated
3130 Lucinactant Treatment of bronchopulmonary dysplasia in premature infants. 10/21/2005 Designated
3131 Lucinactant Treatment of meconium aspiration syndrome in newborn infants 07/30/1996 Designated/Withdrawn
3132 lumacaftor/ivacaftor Treatment of cystic fibrosis 06/30/2014 Designated/Approved
3133 lumacaftor/ivacaftor Treatment of cystic fibrosis 06/30/2014 Designated/Approved
3134 lumacaftor/ivacaftor Treatment of cystic fibrosis 06/30/2014 Designated/Approved
3135 lumasiran Treatment of primary hyperoxaluria type 1 02/08/2016 Designated
3136 lurbinectedin Treatment of ovarian cancer 08/20/2012 Designated
3137 lurbinectedin Treatment of small cell lung cancer (SCLC) 08/01/2018 Designated/Approved
3138 Luspatercept Treatment of myelodysplastic syndrome 03/18/2013 Designated/Approved
3139 luspatercept Treatment of myelofibrosis 01/16/2020 Designated
3140 Luspatercept-aamt Treatment of B-thalassemia 03/11/2013 Designated/Approved
3141 lutetium (177Lu)-edotreotide Treatment of gastro-entero-pancreatic neuroendocrine tumors 05/21/2015 Designated
3142 lutetium Lu 177 dotatate Treatment of gastro-entero-pancreatic neuroendocrine tumors 01/12/2009 Designated/Approved
3143 Lysine acetylsalicylate injectable Treatment of pain and fever secondary to sickle cell disease crisis. 08/01/1989 Designated/Withdrawn
3144 lyso-thermosensitive lipsomal doxorubicin Treatment of hepatocellular carcinoma 03/17/2009 Designated
3145 lysosomal enzyme N-acetylgalactosamine-6-sulfate sulfatase Treatment of mucopolysaccharidosis Type IVA (Morquio Syndrome) 09/10/2008 Designated
3146 MA09-hRPE cells Treatment of Stargardt's macular dystrophy 02/02/2010 Designated
3147 macimorelin acetate Diagnosis of growth hormone deficiency 05/14/2007 Designated/Approved
3148 macitentan Treatment of pulmonary arterial hypertension 09/03/2009 Designated/Approved
3149 macitentan Treatment of chronic thromboembolic pulmonary hypertension (CTEPH) 06/15/2017 Designated
3150 macitentan Treatment of idiopathic pulmonary fibrosis. 04/14/2009 Designated/Withdrawn
3151 macitentan Treatment of Fontan-Palliated patients 06/06/2017 Designated
3152 macitentan and tadalafil, a fixed dose combination formulation Treatment of pulmonary arterial hypertension 10/19/2016 Designated
3153 macromolecular conjugate of heparin sodium on a polymer backbone Prevention of ischemia-reperfusion injury associated with solid organ tranplantation 05/02/2017 Designated
3154 Mafenide acetate solution For use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. 07/18/1990 Designated/Approved
3155 Mafosfamide Treatment of neoplastic meningitis 01/21/2003 Designated
3156 MAGE-A3 cancer therapeutic Trojan peptide vaccine Treatment of MAGE-A3 expressing head and neck squamous cell carcinoma 11/24/2008 Designated
3157 magnesium lysinate bis eicosapentaenoate Treatment of familial adenomatous polyposis. 12/23/2015 Designated
3158 Magnesium lysinate bis Resolvin E1 Treatment of pediatric ulcerative colitis 03/30/2020 Designated
3159 Magrolimab Treatment of Myelodysplastic Syndrome 12/18/2019 Designated
3160 manganese (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of absorption) Use as a targeted contrast agent for diagnostic MRI for the detection and localization of focal liver lesions in patients where use of gadolinium based contrast agents may be medically inadvisable or where gadolinium based contrast agents cannot be administered 09/26/2013 Designated
3161 Manganese butoxyethyl pyridyl porphyrin Treatment of glioma 01/09/2020 Designated
3162 Manganese superoxide dismutase mimetic Prevention of radiation- or chemotherapy-induced oral mucositis in cancer patients 02/27/2008 Designated
3163 Mannitol For use to facilitate clearance of mucus in patients with bronchiectasis and in patients with cystic fibrosis at risk for bronchiectasis 02/11/2005 Designated
3164 mannopentaose phosphate sulfate Treatment of high-risk Stage II, Stage III, and Stage IV melanoma 04/27/2004 Designated
3165 maralixibat Treatment of progressive familial intrahepatic cholestasis 09/04/2013 Designated
3166 margetuximab Treatment of gastric and gastroesophageal junction cancer. 06/03/2020 Designated
3167 maribavir Treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients. 06/07/2011 Designated
3168 maribavir Prevention of cytomegalovirus viremia and disease in the populations at risk. 02/01/2007 Designated
3169 Marijuana Treatment of HIV-associated wasting syndrome. 05/25/1999 Designated
3170 marizomib Treatment of malignant glioma. 09/21/2015 Designated
3171 marizomib Treatment of multiple myeloma 12/13/2013 Designated
3172 MART-1 adenoviral gene therapy for malignant melanoma Treatment of metastatic melanoma. 03/28/1997 Designated/Withdrawn
3173 marzeptacog alfa (activated) Routine prophylaxis to prevent bleeding episodes in patients with hemophilia A and B patients with inhibitors 11/30/2012 Designated
3174 masitinib Treatment of malignant gastrointestinal stromal tumors 04/20/2005 Designated
3175 masitinib Treatment of patients with pancreatic cancer 07/21/2009 Designated
3176 masitinib Treatment of mastocytosis 09/14/2005 Designated
3177 masitinib mesylate Treatment of gastric cancer including cancer of the gastroesophageal junction 09/14/2015 Designated
3178 masitinib mesylate Treatment of amyotrophic lateral sclerosis. 03/18/2015 Designated
3179 Matrix metalloproteinase inhibitor Treatment of corneal ulcers. 12/05/1991 Designated
3180 MaxAdFVIII Treatment of Hemophilia A 03/03/2003 Designated
3181 maytansinoid conjugated humanized monoclonal antibody against FOLRI Treatment of ovarian cancer 07/14/2014 Designated
3182 Maytansinoid DM-1 Conjugated Humanized Monoclonal Antibody N901 Treatment of small cell lung cancer. 08/17/2010 Designated/Withdrawn
3183 maytansinoid DM1-conjugated humanized monoclonal antibody N901 Treatment of Merkel cell carcinoma 03/02/2010 Designated/Withdrawn
3184 maytansinoid DM1-conjugated humanized monoclonal antibody N901 Treatment of multiple myeloma. 11/29/2010 Designated/Withdrawn
3185 Mazindol Treatment of Duchenne muscular dystrophy. 12/08/1986 Designated
3186 mazindol Treatment of narcolepsy 07/06/2016 Designated
3187 MCMV5322A/MCMV3068A Prevention of maternal-fetal transmission of congenital CMV in pregnant women who acquire CMV infection during pregnancy 11/22/2011 Designated/Withdrawn
3188 mebendazole Treatment of single or mixed gastrointestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm), and Ancylostoma duodenale and Nectar americanus (hookworm). 09/03/2014 Designated/Approved
3189 Mecamylamine Treatment of Tourette's syndrome. 10/14/1998 Designated
3190 Mecasermin Treatment of growth hormone insensitivity syndrome. 12/12/1995 Designated/Approved
3191 mecasermin Treatment of amyotrophic lateral sclerosis. 08/05/1991 Designated/Withdrawn
3192 mecasermin Treatment of myotonic dystrophy 12/03/2007 Designated
3193 mecasermin rinfabate Treatment of amyotropic lateral sclerosis 07/23/2012 Designated
3194 mecasermin rinfabate Prevention of retinopathy of prematurity in premature infants born at risk for the disease 09/20/2012 Designated
3195 mecasermin rinfabate Treatment of growth hormone insensitivity syndrome (GHIS) 05/17/2002 Designated/Approved
3196 mecasermin, recombinant human insulin-like growth factor-1 Treatment of Rett Syndrome. 09/21/2015 Designated
3197 meclorethamine Treatment of mycosis fungoides 08/17/2004 Designated/Approved
3198 Medroxyprogesterone acetate Treatment of immune thrombocytopenic purpura. 02/22/2001 Designated
3199 mefloquine HCL For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs 04/13/1988 Designated/Approved
3200 Mefloquine HCl Treatment and prevention of chloroquine-resistant Falciparummalaria 07/22/1987 Designated
3201 mefloquine HCL For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs 04/13/1988 Designated/Approved
3202 Megestrol acetate Treatment of patients with anorexia, cachexia, or significant weight loss (=/>10% of baseline body weight) and confirmed diagnosis of AIDS. 04/13/1988 Designated/Approved
3203 Melanoma autologous dendritic cell vaccine Treatment of stage IIIb through IV metastatic melanoma 09/06/2006 Designated/Withdrawn
3204 Melanoma cell vaccine Treatment of invasive melanoma. 10/13/1994 Designated
3205 Melanoma peptide vaccine Treatment of HLA-A2+ patients with stage IIB, IIC, III, and IV malignant melanoma 03/29/2005 Designated
3206 Melanoma vaccine Treatment of stage III - IV melanoma. 12/20/1989 Designated
3207 melarsoprol-hydroxypropylbetadex Treatment of human African trypanosomiasis (sleeping sickness) 09/13/2013 Designated
3208 melatonin Treatment of necrotizing enterocolitis 01/25/2017 Designated
3209 melatonin Treatment of perinatal asphyxia 03/08/2018 Designated
3210 melatonin Treatment of smith-magenis syndrome in combination with a beta-blocker 11/03/2016 Designated
3211 melatonin Treatment of hepatocellular carcinoma 02/28/2019 Designated
3212 Melatonin Prevention of retinopathy of prematurity 04/20/2020 Designated
3213 melatonin Treatment of neonatal hypoxic ischemic encephalopathy 04/12/2013 Designated
3214 melatonin Treatment of pancreatic cancer 10/09/2019 Designated
3215 melatonin Treatment of acute acetaminophen overdose 03/02/2017 Designated
3216 Melatonin Treatment of retinopathy of prematurity 04/20/2020 Designated
3217 Melatonin Treatment of primary intracerebral hemorrhage 01/22/2020 Designated
3218 melatonin Treatment of short bowel syndrome 02/14/2017 Designated
3219 Melatonin Treatment of non-24-hour sleep-wake disorder in blind individuals without light perception 07/09/2004 Designated
3220 Melatonin Treatment of circadian rhythm sleep disorders in blind people with no light perception. 11/15/1993 Designated
3221 melatonin Treatment of subarachnoid hemorrhage 03/28/2018 Designated
3222 Melatonin Treatment of heat stroke 04/22/2019 Designated
3223 melatonin Treatment of Acute Radiation Syndrome 10/22/2018 Designated
3224 meloxicam Treatment of juvenile rheumatoid arthritis 11/22/2002 Designated/Approved
3225 melphalan Treatment of retinoblastoma 11/19/2012 Designated
3226 Melphalan For use in hyperthermic regional limb perfusion to treat metastatic melanoma of the extremity. 03/03/1992 Designated/Withdrawn
3227 Melphalan Treatment of patients with multiple myeloma for whom oral therapy is inappropriate. 02/24/1992 Designated/Approved
3228 melphalan High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation 11/24/2008 Designated/Approved
3229 melphalan Treatment of cholangiocarcinoma. 07/14/2015 Designated
3230 melphalan Treatment of Stage IIB through IV melanoma 11/19/2012 Designated
3231 melphalan flufenamide hydrochloride Treatment of plasma cell myeloma, also referred to as multiple myeloma 03/16/2015 Designated
3232 melphalan hydrochloride Treatment of patients with cutaneous melanoma. 11/12/2008 Designated
3233 melphalan hydrochloride Treatment of patients with hepatocellular carcinoma 09/26/2013 Designated
3234 melphalan hydrochloride Treatment of neuroendocrine tumors 05/22/2009 Designated
3235 melphalan hydrochloride Treatment of patients with ocular (uveal) melanoma. 11/12/2008 Designated
3236 menadione sodium bisulfite Treatment of autosomal dominant polycystic liver disease 05/14/2014 Designated
3237 Menadione Sodium Bisulfite For the treatment of autosomal dominant polycystic kidney disease 05/14/2014 Designated
3238 menaquinone Treatment of calciphylaxis 09/04/2012 Designated
3239 menatetrenone Treatment of acute myeloid leukemia 03/17/2011 Designated
3240 menatetrenone Treatment of acute promyelocytic leukemia. 11/02/2010 Designated
3241 menatetrenone Treatment of hepatocellular carcinoma (HCC). 11/02/2010 Designated
3242 menatetrenone Treatment of myelodysplastic syndrome. 02/04/2011 Designated
3243 menatetrenone and Vitamin D3 Treatment of myelodysplastic syndrome 08/22/2011 Designated
3244 mepivacaine Treatment of postherpetic neuralgia 01/08/2007 Designated
3245 mepivacaine Treatment of painful HIV-associated neuropathy 10/18/2006 Designated
3246 meplazumab Treatment of malaria 03/15/2019 Designated
3247 mepolizumab For first-line treatment in patients with hypereosinophilic syndrome 05/28/2004 Designated
3248 mepolizumab Treatment of Churg-Strauss Syndrome 07/14/2011 Designated/Approved
3249 mepolizumab Treatment of Churg-Strauss Syndrome 07/14/2011 Designated/Approved
3250 mercaptopurine oral solution Treatment of acute lymphoblastic leukemia in pediatric patients 08/20/2012 Designated/Approved
3251 merestinib Treatment of biliary tract cancer 04/10/2017 Designated
3252 Meropenem Management of acute pulmonary exacerbations, in cystic fibrosis patients, due to respiratory tract infection with susceptible organisms. 04/27/2000 Designated/Withdrawn
3253 mesalamine Treatment of pediatric ulcerative colitis 01/19/2010 Designated
3254 mesalamine and N-acetycysteine Treatment of pediatric patients with ulcerative colitis (inclusive through age 16 years) 09/10/2009 Designated
3255 mesalamine; 5-aminosalicylic acid Treatment of ulcerative colitis in pediatric patients (revised indication 10/21/2010). 02/27/2008 Designated
3256 mesencephalic, astrocyte-derived neurotrophic factor Treatment of retinal artery occlusion. 09/10/2015 Designated
3257 mesenchymal stromal cells secreting neurotrophic factors Treatment of Amyotrophic Lateral Sclerosis 02/04/2011 Designated
3258 Mesna Inhibition of the urotoxic effects induced by oxazaphosphorine compounds such as cyclophosphamide. 12/16/1987 Designated/Withdrawn
3259 Mesna For use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. 11/14/1985 Designated/Approved
3260 messanger ribonucleic acid (mRNA)-based therapeutic agent encoding human methylmalonyl-coenzyme A mutase Treatment of isolated methylmalonic academia (MMA) due to methylmalonyl-Coenzyme A mutase (MUT) deficiency 03/07/2018 Designated
3261 messenger ribonucleic acid-based therapeutic agent encoding human propionyl-CoA carboxylase alpha and beta subunits Treatment of propionic acidemia. 12/05/2018 Designated
3262 mesylate synthetic small molecule inhibitor of HDAC and PI3K Treatment of nuclear protein in testis (NUT) midline carcinoma 09/06/2016 Designated
3263 met-enkephalin; Met-N Treatment of pancreatic cancer. 02/18/2011 Designated
3264 metadoxine Treatment of Fragile X Syndrome 12/16/2013 Designated
3265 metavert, N-hydroxy-4-(5-((4-methoxyphenyl)amino)-1,3,4-oxadiazol-2-yl)benzamide Treatment of pancreatic cancer 07/06/2016 Designated
3266 metformin Treatment of progressive myoclonus epilepsy type 2 (Lafora disease) 12/14/2017 Designated
3267 metformin Treatment of pediatric polycystic ovary syndrome 05/29/2014 Designated
3268 [[Methanesulfonate-1-sec-butoxycarbonyloxymethyl-1-methyl-4-{4-4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenylcarbamoyl-benzyl}-piperazin-1-ium]] Treatment of chronic myeloid leukemia 09/13/2018 Designated
3269 methimazole and liothyronine sodium Treatment of glioblastoma multiforme. 06/02/2016 Designated
3270 Methionine/L-methionine Treatment of AIDS myelopathy. 08/21/1996 Designated
3271 methotrexate Prevention of proliferative vitreoretinopathy (PVR) 04/11/2018 Designated
3272 methotrexate Treatment of ectopic pregnancy 03/25/2019 Designated
3273 Methotrexate Treatment of Myasthenia Gravis 08/28/2014 Designated
3274 methotrexate Treatment of juvenile rheumatoid arthritis. 08/23/1993 Designated/Withdrawn
3275 methotrexate Treatment of acute lymphoblastic leukemia 08/20/2009 Designated
3276 methotrexate oral liquid formulation Treatment of acute lymphoblastic leukemia in pediatric patients aged 0 through 16 years. 03/18/2015 Designated
3277 methotrexate oral solution Treatment of acute lymphoblastic leukemia in pediatric patients (0 through 16 years of age) 05/28/2015 Designated/Approved
3278 methotrexate oral solution Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy. 08/27/2015 Designated/Approved
3279 Methotrexate sodium Treatment of osteogenic sarcoma. 10/21/1985 Designated/Approved
3280 Methotrexate with laurocapram Topical treatment of mycosis fungoides. 10/15/1990 Designated
3281 Methoxsalen For use in conjunction with the UVAR photopheresis system to treat graft versus host disease. 10/14/1998 Designated
3282 methoxsalen For the prevention of acute rejection of cardiac allografts 05/12/1994 Designated
3283 [[methyl (2R,3S)-3-(methylsulfonyl)amino-2-{(cis-4-phenylcyclohexyl)oxymethyl}piperidine-1-carboxylate]] Treatment of narcolepsy 12/19/2017 Designated
3284 [[Methyl O-4-O-2-2-2-2-N-(1R)-1-4-(aminoiminomethyl)phenylmethyl-2-oxo-2-(1-piperidinyl)ethyl-N2-(4-methoxy-2,3,6-trimethylphenyl)sulfonyl-L-Ã?ÂÃÃ?Ã?Â&Ã?ýÃ?ÂÃÃ?ÂÃ?ñ-aspararginyl-4-aminobutanoyl-N6-5-(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno]] Prevention of ischemia reperfusion injury associated wth solid organ transplantation 04/18/2011 Designated
3285 methyldopa Treatment of type 1 diabetes in DQ8 positive patients with residual beta cell function 01/12/2017 Designated
3286 methylene blue Treatment of methemoglobinemia 07/24/2012 Designated
3287 methylene blue injection Treatment of congenital and acquired methemoglobinemia 08/11/2012 Designated
3288 methylene blue0.5% Treatment of hereditary and acquired methemoglobinemia 12/18/2012 Designated/Approved
3289 Methylnaltrexone Treatment of chronic opioid-induced constipation unresponsive to conventional therapy. 06/17/1996 Designated/Withdrawn
3290 methylparaben suberohydroxamic acid phenyl ester Treatment of cutaneous T-cell lymphoma 04/15/2013 Designated
3291 methylprednisolone oral suspension Treatment of adrenal insufficiency in pediatric patients 09/19/2016 Designated
3292 metreleptin Treatment of leptin deficiency secondary to generalized lipodystrophy and partial familial lipodystrophy 08/22/2001 Designated
3293 metreleptin Treatment of metabolic disorders secondary to lipodystrophy 08/22/2001 Designated/Approved
3294 metronidazole Treatment of pouchitis 04/26/2011 Designated
3295 metronidazole Treatment of pouchitis 09/17/2008 Designated
3296 metronidazole Treatment of clostridium difficile infection in pediatric patients (0 through 16 years of age). 04/05/2016 Designated
3297 Metronidazole Treatment of perioral dermatitis. 10/24/1991 Designated
3298 Metronidazole (topical) Treatment of grade III and IV, anaerobically infected, decubitus ulcers. 11/24/1987 Designated/Withdrawn
3299 Metronidazole (topical) Treatment of acne rosacea. 10/22/1987 Designated/Approved
3300 Metronidazole 10% ointment Topical treatment of active perianal Crohn's disease 11/08/2007 Designated
3301 metyrapone Treatment of Cushing's syndrome 09/25/2012 Designated
3302 metyrosine Treatment of velocardiofacial syndrome associated psychosis. 07/25/2008 Designated
3303 mexiletine Treatment of nondystrophic myotonia 09/02/2010 Designated
3304 mexiletine Treatment of myotonic disorders 03/16/2020 Designated
3305 mibefradil Treatment of pancreatic cancer. 10/16/2008 Designated
3306 mibefradil Treatment of glioblastoma multiforme. 08