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: fosdenopterin
Trade Name: Nulibry
Date Designated: 11/05/2009
Orphan Designation: Treatment of molybdenum cofactor deficiency type A (MoCD)
Orphan Designation Status: Designated/Approved
Origin Biosciences, Inc.
75 Park Plaza
Boston, Massachusetts 02116
United States

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

Marketing approved:

1 Generic Name: fosdenopterin
Trade Name: Nulibry
Marketing Approval Date: 02/26/2021
Approved Labeled Indication: to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A
Exclusivity End Date: 02/26/2028 
Exclusivity Protected Indication* :  to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-