Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

Drug firm Glenmark Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for generic Dapagliflozin tablets used for treatment of type-2 diabetes.

The product is a generic version of AstraZeneca AB's Farxiga tablets.

"Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Dapagliflozin tablets, 5 mg and 10 mg," Glenmark said in a filing to BSE.

Citing IQVIA sales data for the 12 month period ending January 2020, the company said Farxiga tablets, brand and all available therapeutic equivalents in strengths of 5 mg and 10 mg, achieved