Glenmark Pharma receives 2nd tentative approval from USFDA for generic diabetes tablets
Glenmark Pharmaceuticals Ltd announced that its US subsidiary has received the second tentative approval from the United States Food and Drug Administration (USFDA) for Saxagliptin Tablets, 2.5 mg and 5 mg. The Saxagliptin Tablets are the generic version of Onglyza tablets of AstraZeneca.
The global pharmaceutical major had received the first tentative approval from USFDA for Saxagliptin Tablets, 2.5 mg and 5 mg in June 2017.
Onglyza tablets are used to control blood sugar levels and treat type 2 diabetes mellitus.
Onglyza tablets, 2.5 mg and 5 mg, had annual sales of approximately $122.3 million in the US in the 12-month period ending December 2022, according to IQVIA sales data.
The USFDA issues a tentative approval letter to an applicant before the final approval of the generic drug product until all patent or exclusivity issues are resolved. A tentative approval does not allow the applicant to market the generic drug product.
Glenmark’s current portfolio consists of 179 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the USFDA.
The company last month announced receiving tentative approval from the US drug regulator for its generic Regadenoson injection.