Glenmark gets tentative USFDA approval for generic anti-diabetes tablets

The approval is for the strength of 10 mg/5 mg tablets of Dapagliflozin and Saxagliptin

Glenmark Pharmaceuticals has received tentative approval from the US health regulator for its generic Dapagliflozin and Saxagliptin anti-diabetes tablets.

The approval granted by the United States Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, US, is for the strength of 10 mg/5 mg tablets, the generic version of Qtern tablets of the same strength of AstraZeneca AB, the company said in a statement.

Citing IQVIA sales data for the 12-month period ending February 2020, the company said Qtern tablets, 10 mg/5 mg had achieved annual sales of approximately USD 10.4 million.

Glenmark’s current portfolio consists of 162 products authorised for distribution in the US and 44 abbreviated new drug applications pending approval with the USFDA, the company said.