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Xarelto Expanded Indication May Depend On Containing Worries About Bleeding

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA advisory committee will review J&J/Bayer’s anticoagulant for a claim of reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. The product has a profoundly stronger database, but the same set of safety concerns, compared to when it was initially approved.

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