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Xarelto Faces Approval, Labeling Obstacles Even After Cmte. Endorsement

Executive Summary

Bayer and Johnson & Johnson may have won the battle in securing an FDA advisory committee endorsement of Xarelto (rivaroxaban) for atrial fibrillation, but they may well lose the war of the novel anticoagulants given the panel’s unfavorable labeling recommendations if the oral Factor Xa inhibitor is approved.
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