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Rivaroxaban review scheduled

Executive Summary

The Cardiovascular and Renal Drugs Advisory Committee will meet March 19 to review Johnson & Johnson/Bayer's novel factor Xa inhibitor Xarelto (rivaroxaban) for prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery, FDA announces. The NDA has a PDUFA date of May 29, 2009. The application is based on four Phase III studies - known as RECORD 1-4 - involving more than 12,500 patients (1"The Pink Sheet" DAILY, July 30, 2008). Bayer launched the oral anticoagulant in Europe in October 2008

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