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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
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)
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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