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The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).


Dabigatran 150mg was superior to warfarin and dabigatran 110mg was noninferior to warfarin for preventing stroke in patients with atrial fibrillation (AF) regardless of CHA2DS2-VASc scores, as shown by the results of a subgroup analysis of the RE-LY trial presented today at ACC.11, the American College of Cardiology’s 60th Annual Scientific Session.