Glenmark Pharmaceuticals receives USFDA tentative approval for Saxagliptin Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received a 2nd tentative approval by the United States Food & 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. Glenmark's first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on 12 June 2017.

According to IQVIATM sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market2 achieved annual sales of approximately $122.3 million.

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