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.
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
Related Fool Articles
Recent Mentions on Fool.com
- 3 Stocks to Get on Your Watchlist
- This is the 1 Thing AstraZeneca Should Do to Improve Shareholder Value
- Here's What You Need to Know About Alexion Pharmaceuticals' Upcoming Earnings
- 4 Reasons You Should Watch This Under-the-Radar Stock on Your Watchlist
- How Are Orphan Drugmakers Faring in the Great Biotech Downturn?
- 2 Biotech Stocks to Watch: Merrimack Pharmaceuticals and Sunesis Pharmaceuticals