Glenmark Pharma gets US FDA nod for Saxagliptin Tablet
The company received the final USFDA approval for generic diabetes drug Saxagliptin Tablets 2.5 mg and 5 mg, the generic version of Onglyza Tablets of AstraZeneca AB.
Hyderabad: Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, integrated, global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets.
A generic diabetes drug Saxagliptin Tablets 2.5 mg and 5 mg, is the generic version of Onglyza 1 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $100.7 million.
Glenmark’s current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.