Bristol-Myers Squibb and Pfizer announced today that the European Commission has approved ELIQUIS® (apixaban) for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors. ELIQUIS is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class.
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015. PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The recall is limited to this one lot number.