Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: vamorolone
Trade Name: Agamree
Date Designated: 12/02/2011
Orphan Designation: Treatment of Duchenne muscular dystrophy
Orphan Designation Status: Designated/Approved
Catalyst Pharmaceuticals, Inc.
355 Alhambra Circle, Suite 801
Coral Gables, Florida 33134
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: vamorolone
Trade Name: Agamree
Marketing Approval Date: 10/26/2023
Approved Labeled Indication: Treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older
Exclusivity End Date: 10/26/2030 
Exclusivity Protected Indication* :  Treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-