Glenmark gets tentative approval from US FDA for Axitinib Tablets, 1 mg and 5 mg
These tablets are indicated in the treatment of kidney cancer
Glenmark Pharmaceuticals has received tentative approval by the United States Food & 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 C.V.
According to IQVIATM sales data for the 12 month period ending October 2020, the Inlyta Tablets, 1 mg and 5 mg market2 achieved annual sales of approximately $518.8 million*.
Glenmark’s current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.