Glenmark gets USFDA nod for generic lung cancer drug, Health News, ET HealthWorld

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Glenmark gets USFDA nod for generic lung cancer drugGlenmark Pharmaceuticals on Friday said it has received approval from the US health regulator to marketreg Nintedanib Capsules, used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer, in the US market.

The Mumbai-based drug major has received preliminary approval from the US Food and Drug Administration (USDA) to market the product in 100 and 150 mg strengths, Glenmark Pharmaceuticals said in a statement.

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The company’s product is the generic version of Boehringer Ingelheim Pharmaceuticals Inc.’s Ofev capsules.

According to IQVIA sales data for the 12-month period ending April 2021, Ofev capsules (100mg and 150mg) had achieved annual sales of approximately USD 1.6 billion.

Glenmark said its current portfolio consists of 172 products approved for distribution in the US market and 44 abbreviated new ones drug applications (ANDAs) pending approval with the USFDA.

In addition to these internal filings, the drugmaker continues to identify and explore external development partnerships to complement and accelerate the growth of its existing pipeline and portfolio, it added.

Glenmark has a generics, specialty and OTC business with operations in more than 50 countries.

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