Glenmark gets second tentative ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg

Glenmark Pharmaceuticals has received a second tentative approval by the United States Food & Drug Administration (US FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on June 12, 2017.

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $122.3 million*.

Glenmark’s current portfolio consists of 179 products authorised for distribution in the US marketplace and 46 ANDAs pending approval with the US FDA.