Orphan Designation Granted Letter
- Posted by: Ken Phelps
- Published on: March 27, 2013
Camargo is privileged to work with many clients to develop Orphan drugs. In order to obtain an Orphan drug approval the sponsor must first request that the drug and indication be granted orphan-drug designation. This process requires research into both the indication and the potential population. If the FDA’s Office of Orphan Products Development agrees, it issues a letter to the sponsor granting this designation. I thought I’d share our most recent such letter (13 and counting!). The drug is also listed on the FDA’s Orphan Drug Designations and Approvals database.