Boehringer Ingelheim announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).

The sNDA is based on results from four global Phase 3 studies evaluating the efficacy and safety of dabigatran in the treatment of this condition, specifically RE-COVER I and II, RE-MEDY, and RE-SONATE.

Pradaxa is currently approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).

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