FDA Assigns Priority Review for Rivaroxaban's New Drug Application
February 28, 2012 — Janssen Research and Development LLC announced that the U.S. Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental new drug application (sNDA) filed Dec. 29, 2011 for Xarelto (rivaroxaban), an oral anticoagulant to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). Under the Prescription Drug User Fee Act, FDA will complete its review within six months from the receipt of the sNDA submission, rather than the standard 10-month review cycle.
The submission was based on results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial that were presented in November 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine.
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