Blog & Resources Camargo Blog March 27th, 2013

Orphan Designation Granted Letter

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.

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
2505 Meridian Parkway
Suite 150
Durham NC, 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights