Glenmark gets USFDA nod for Single-Dose Prefilled Icatibant Injection
Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.
The product is a generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.
This marks Glenmark'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 U.S. marketplace and 44 ANDA's pending approval with the USFDA.