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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).

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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.