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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  carglumic acid
Trade Name:  Carbaglu
Date Designated:  01/20/1998
Orphan Designation:  Treatment of N-acetylglutamate synthetase deficiency.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/18/2010 
Approved Labeled Indication:  As an adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS) and as manitenance therapy for chronic hyperammonemia due to NAGS deficiency
Exclusivity End Date:    03/18/2017 
Exclusivity Protected Indication* :  
Orphan Europe SARL
Immeuble Le Wilson
70 avenue du General de Gaulle

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.