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12:00 AM
Sep 27, 2010
 |  BC Week In Review  |  Clinical News  |  Regulatory

Pradaxa dabigatran etexilate regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-0 that Boehringer's Pradaxa dabigatran should be approved for the reduction of stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee made its decision based on results from the Phase III RE-LY trial, which showed that each dose of Pradaxa studied (110 and 150 mg twice daily) was non-inferior to open-label, adjusted-dose warfarin on the primary endpoint...

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