Xarelto to Receive Priority FDA Review for DVT and PE Indications; Company Withdraws sNDA for Stent Thrombosis in ACS
July 9, 2012—Janssen Research & Development, LLC (Janssen R&D, Raritan, NJ) announced that the US Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012, for the oral anticoagulant Xarelto (rivaroxaban), seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.
