Glenmark Pharmaceuticals gets FDA second tentative approval for Saxagliptin Tablets

Glenmark Pharmaceuticals Inc., USA has secured a second tentative approval from the United States Food and Drug Administration (FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg.

The product that has been approved is the generic version of type 2 diabetes drug Onglyza Tablets. 2.5 mg, and five mg, from AstraZeneca.

The first tentative approval letter from the FDA to Glenmark Pharmaceuticals for Saxagliptin Tablets, 2.5 mg and 5 mg was issued on 12 June 2017.

As per the IQVIA data on sales for the 12 months ending December 2022, Onglyza Tablets 2.5 mg and the 5 mg market clocked annual sales of nearly $122.3 million.

Glenmark Pharmaceuticals’ portfolio currently comprises 179 products that are authorized to be sold in the US marketplace and 46 abbreviated new drug applications (ANDAs) that are awaiting approval from the FDA.