Glenmark Gets USFDA Nod For Generic Diabetes Drug

Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added.

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace.
The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added.

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 stated.