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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
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
Origin Biosciences, Inc.
75 Park Plaza
Boston, Massachusetts 02116
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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