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August 13, 2003 | The FDA has designated more than 1,000 orphan products and approved more than 200 for marketing. Approval time for orphan products has historically been "considerably shorter" than for other drugs, the FDA says, because many are for treatment of life-threatening diseases. Sponsors of orphan drugs receive certain benefits from the government in exchange for developing them, such as tax credits.

Some of the rare diseases now treated by orphan drugs:

· Cystic fibrosis

· Sickle cell anemia

· Huntington's disease

· T-cell lymphoma

· Hansen's disease

· Juvenile rheumatoid arthritis

For more information

FDA Office of Orphan Products Development

National Organization for Rare Disorders

Office of Rare Diseases, NIH

Back to Orphan Drugs: For Love or Money? 

For reprints and/or copyright permission, please contact Terry Manning, 781.972.1349.