Glenmark gets tentative approval from US FDA for Axitinib Tablets, 1 mg and 5 mg

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.