Glenmark gets final go from FDA for Icatibant injection

Glenmark Pharmaceuticals Limited has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the 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 facility based in Monroe, North Carolina.

Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
(Source: Glenmark)

2021-05-24T15:17:38+02:00May 24, 2021|HAEi News|