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Xarelto's Comparative Efficacy To Warfarin, Pradaxa Will Be Focus At FDA Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will ask its Cardiovascular and Renal Drugs Advisory Committee whether Bayer/Johnson & Johnson's anticoagulant rivaroxaban must be shown to be "as effective" as warfarin and/or Boehringer Ingelheim's dabigatran at preventing stroke in atrial fibrillation patients.

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With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.

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