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Bayer/J&J Will Resubmit Xarelto For Acute Indication In Second Half Along With New Application For Chronic Use

This article was originally published in The Pink Sheet Daily

Executive Summary

Chronic use application may help ease FDA's reluctance to make available a much anticipated and broadly applicable anticoagulant for the acute application in the original NDA.

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Xarelto Atrial Fibrillation Data Suggest Lines Of Advisory Committee Inquiry

Published results from the Xarelto (rivaroxaban) pivotal trial in atrial fibrillation throw more light on the efficacy and safety concerns likely to be aired at a Sept. 8 FDA advisory committee review of the Bayer/Johnson & Johnson anticoagulant.

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Simultaneously, partner Bayer submits applications in Europe, where rivaroxaban already is approved, for those indications and one more.

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