Orphan drug
The FDA gives an orphan drug designation to drug candidates that treat a disease that affects less than 200,000 persons in the United States.
Expanded Definition
The designation is designed to give financial incentives to drugmakers so that drugs for rare diseases will be developed. Those include:
- A 50% tax credit on clinical trial costs
- A break from paying Prescription Drug User Fee Act fees
- The all-important seven years of exclusive sales
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