Health Canada grants marketing authorization to Recordati's Carbaglu

9 September 2015

Health Canada has granted marketing authorization for Carbaglu (carglumic acid) from Italian pharma company Recordati (REC: MI) .

The drug has been approved as an adjunctive therapy in the treatment of acute hyperammonemia or as maintenance therapy for chronic hyperammonemia due to a deficiency of the hepatic enzyme N-aceytlglutamate synthase. The approval covers pediatric and adult indications. It is the only product authorized for sale by Health Canada as an adjunctive therapy for this indication.

Carbaglu is currently marketed in Europe and many other countries by Orphan Europe, a unit of Recordati since 2007.

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