Glenmark Pharma gets USFDA nod for Icatibant injection

CHENNAI: Pharma major Glenmark Pharmaceuticals Limited on Monday said it has received the final approval from the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

The injection is the generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.

According to Glenmark, this is the company's first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

According to IQVIA sales data for the 12 month period ending March 2021, the Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market achieved annual sales of approximately $223.4 million.

Glenmark's current portfolio consists of 172 products authorized for distribution in the US marketplace and 44 abbreviated new drug application (ANDA) pending approval with the USFDA.