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Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug

Glenmark's current portfolio consists of 166 products authorised for distribution in the US market and 45 ANDA's pending approval with the USFDA.

Published: 01st December 2020 11:29 AM  |   Last Updated: 01st December 2020 11:29 AM   |  A+A-

Pharmaceutical tablets and capsules are arranged on a table in a photo illustration

For representational purposes (File Photo | Reuters)

By PTI

NEW DELHI: Drug major Glenmark Pharma on Tuesday said it has received tentative approval from the US health regulator for Axitinib tablets, used in the treatment of kidney cancer. The tentatively approved product is the generic version of Inlyta tablets of PF Prism CV.

Glenmark Pharmaceuticals Inc, USA has received tentative approval by the United States Food & Drug Administration (USFDA) for Axitinib tablets in the strength of 1 mg and 5 mg, the company said in a regulatory filing.

Quoting IQVIA sales data for the 12 months ending October 2020, Glenmark Pharma said the Inlyta Tablets, 1 mg and 5 mg market achieved annual sales of approximately USD 518.8 million.

Glenmark's current portfolio consists of 166 products authorised for distribution in the US market and 45 ANDA's pending approval with the USFDA.



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