Glenmark Pharma receives 2nd US FDA tentative approval for generic Onglyza tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received a 2nd tentative approval by the United States Food & Drug Administration (FDA) for saxagliptin tablets, 2.5 mg and 5 mg, the generic version of Onglyza 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 June 12, 2017.

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

Glenmark’s current portfolio consists of 179 products authorized for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA. 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.

Glenmark Pharmaceuticals Ltd. is an innovation-driven, global pharmaceutical company with a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.