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Carbaglu Approval History

FDA Approved: Yes (First approved March 18, 2010)
Brand name: Carbaglu
Generic name: carglumic acid
Dosage form: Tablets
Company: Orphan Europe
Treatment for: Hyperammonemia

Carbaglu (carglumic acid) is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated for the treatment of hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).

Development History and FDA Approval Process for Carbaglu

DateArticle
Mar 18, 2010Approval FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels

Further information

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