Glenmark Pharma gets USFDA nod for Icatibant injection for angioedema treatment

Hereditary angioedema is a disorder that results in recurrent attacks of severe swelling.

Published: 24th May 2021 11:38 AM  |   Last Updated: 24th May 2021 11:38 AM   |  A+A-

Glenn Saldanhaa, Glenmark Pharmaceuticals

Glenmark Pharmaceuticals CEO Glenn Saldanhaa (Photo| Facebook/ Mex Studios)


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.

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.


Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on are those of the comment writers alone. They do not represent the views or opinions of or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp