NEW DELHI: Drug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules.
The approved product is a generic version of Boehringer Ingelheim Pharmaceuticals' Pradaxa capsules. Pradaxa is used to prevent blood clots from forming because of certain irregular heart rhythm.
Glenmark Pharmaceuticals has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Dabigatran Etexilate capsules in the strengths of 75 mg, 110 mg, and 150 mg, the company said in a regulatory filing.
Quoting IQVIA sales data for the 12 month period ending August 2020, Glenmark said Pradaxa capsules, 75, 110 mg and 150 mg, market achieved annual sales of approximately USD 550.9 million.
Glenmark said its current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 abbreviated new drug applications are pending approval with the USFDA. Shares of the company were trading 2.32 per cent higher at Rs 528 per scrip on the BSE.