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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
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.

Marketing approved:

1 Generic Name: carglumic acid
Trade Name: Carbaglu
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* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.