Glenmark gets USFDA nod for generic version of AstraZeneca diabetes drug Onglyza

Mumbai: Glenmark Pharmaceuticals Ltd., a research‐led, integrated, global pharmaceutical company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg. The product is a generic version of diabetes drug Onglyza, 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 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.

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