The drug maker said that it has received second tentative approval by US Food & Drug Administration for Saxagliptin tablets, 2.5 mg and 5 mg.
Saxagliptin is used to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors.The said drug is a generic version of Onglyza tablets of AstraZeneca AB. Saxagliptin tablets received first tentative approval on 12 June 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 U.S. marketplace and 46 ANDA's pending approval with the U.S.FDA.
Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.
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