Glenmark Pharmaceuticals Gets USFDA Nod For Saxagliptin Tablets
Glenmark Pharmaceuticals, an Indian pharmaceutical company has received final approval from the United States Food and Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza1 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB, the company said in an exchange filing on Tuesday.
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 market2 achieved annual sales of approximately USD 100.7 million. The Saxagliptin Tablets are indicated to lower sugar levels (type 2 diabetes) when used with diet and exercise.
Glenmark’s current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 49 ANDAs 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.
