Glenmark gets USFDA’s tentative nod for Saxagliptin tablets

Drug firm Glenmark has received tentative nod from the US health regulator for Saxagliptin tablets. “Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration for Saxagliptin tablets, 2.5 mg and 5 mg, the generic version of Onglyza tablets, 2.5 mg and 5 mg of AstraZeneca AB,” the company said in a BSE filing today.

According to IMS Health sales data for the 12-month period ending April 2017, the Onglyza tablets, 2.5 mg and 5 mg market achieved annual sales of approximately USD 518.5 million. Glenmark’s current portfolio consists of 117 products authorised for distribution in the US marketplace and 68 ANDA’s pending approval with the USFDA, it said.

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, it added.