Glenmark Pharmaceuticals receives ANDA tentative approval for Axitinib tablets

The generic version of Inlyta Tablets, 1 mg, and 5 mg


Glenmark Pharmaceuticals USA (Glenmark) has received tentative approval by the United States Food and Drug Administration (US FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta Tablets, 1 mg and 5 mg, of PF Prism CV.

Inlyta is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC) when 1 prior drug treatment regimen for your RCC has not worked. It is not known that Inlyta is safe and effective in children.

According to IQVIATM sales data for the 12 months ending October 2020, the Inlyta Tablets, 1 mg, and 5 mg market achieved annual sales of approximately $518.8 million.

Glenmark’s current portfolio consists of 166 products authorized for distribution in the US marketplace and 45 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate its existing pipeline and portfolio growth.


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