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Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug

Drug major Glenmark Pharma on Tuesday said it has received tentative approval from the US health regulator for Axitinib tablets

Glenmark Pharmaceuticals | USFDA | cancer drugs

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals
Glenmark Pharmaceuticals

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.

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

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Tue, December 01 2020. 11:27 IST