Glenmark Pharma gets USFDA nod for Icatibant Injection

Indicated for the treatment of acute attacks of hereditary angioedema (HAE).

New Delhi: Drug major Glenmark Pharma on Monday said it has received final approval from the US health regulator for Icatibant Injection, indicated for the treatment of acute attacks of hereditary angioedema (HAE).

Hereditary angioedema (HAE) is a disorder that results in recurrent attacks of severe swelling.
The approved product is a generic version of Firazyr Injection of Shire Human Genetic Therapies, Inc.

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Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, the company said in a regulatory filing.

Quoting IQVIA sales data for the 12 months ending March 2021, Glenmark said Firazyr Injection, 30 mg/3 mL single-dose prefilled syringe market achieved annual sales of approximately USD 223.4 million.

The drug firm said its current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications are pending approval with the USFDA.

Shares of Glenmark Pharma were trading 1.26 per cent higher at Rs 615 apiece.