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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: 06/17/2014
Orphan Designation: Treatment of organic acidemias
Orphan Designation Status: Designated/Approved
Recordati Rare Diseases
Immeuble Le Wilson
70 avenue du General de Gaulle
Puteaux
France

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: 01/22/2021
Approved Labeled Indication: in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)
Exclusivity End Date: 01/22/2028 
Exclusivity Protected Indication* :  in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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