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The Xarelto Trials That Might Have Been

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) was cleared for stroke prevention in atrial fibrillation patients unencumbered by new post-marketing studies – but not for lack of suggestions. FDA reviewers had urged further studies on topics ranging from alternate dosing regimens and reversal of drug activity to transitioning to warfarin.

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