The United States Food and Drug Administration (U. S. FDA) has granted Glenmark Pharmaceuticals Inc., USA (Glenmark) a second tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of AstraZeneca AB’s Onglyza1 Tablets, 2.5 mg and 5 mg. Glenmark received its first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg, on June 12, 2017.
According to IQVIATM sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market2 generated approximately $122.3 million in annual sales.