Glenmark Pharmaceuticals Inc. on Friday announced that it has received a second tentative approval by the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg.
The drug is 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 TM sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market 2 achieved annual sales of approximately $122.3 million.
Glenmark’s current portfolio consists of 179 products authorized for distribution in the U.S. marketplace and 46 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.