Glenmark Pharmaceuticals Ltd. on Tuesday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg.
According to the company’s press statement, the generic version of Onglyza 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 IQVIA TM sales data for the 12-month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market 2 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.