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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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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 Jan. 1, 2013, to the present.
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