Boehringer Ingelheim received approval from the FDA for Pradaxa (dabigatran etexilate), an oral direct thrombin inhibitor 2 for stroke risk reduction in patients with non-valvular atrial fibrillation (AF). This is the first approval of a new oral anticoagulant in the U.S. in more than 50 years. The approval is based on results from the RE-LY study, demonstrating that dabigatran etexilate 150 mg significantly reduced the risk of stroke and systemic embolism by 35% compared to warfarin, the st...