Orphan drug

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Orphan drug is a designation by the United States FDA for a drug that is used to treat, prevent, or diagnose an orphan disease.

Orphan disease

An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States.


Orphan diseases are often serious or life threatening.

US law

In 1983, the U.S. government passed a law, called the Orphan Drug Act, to give drug companies certain financial benefits for developing orphan drugs that are safe and effective.

Partial list of orphan drugs


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