Glenmark gets tentative US FDA nod for anti-coagulant drug

The product is the generic version of Pradaxa capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals

Glenmark Pharmaceuticals has received tentative nod from the US health regulator for anti-coagulant medication Dabigatran Etexilate capsules. "Glenmark Pharmaceuticals, USA has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg," Glenmark Pharmaceuticals said in a BSE filing.

The product is the generic version of Pradaxa capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, it added.

According to IMS Health sales data for the 12 months to February 2017, the approved product has achieved annual sales of around $913 million, Glenmark said.

The company’s current portfolio consists of 114 products authorised for distribution in the US marketplace and 65 Abbreviated New Drug Applications (ANDA) pending approval with the US FDA.