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The US health regulator has provided its tentative approval to Glenmark Pharmaceuticals for anti-coagulant medication Dabigatran Etexilate capsules.
Glenmark has said in a BSE filing that “Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg.”
It added that the product is the generic version of Pradaxa capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.
