The U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against the approval of the use of oral anticoagulant Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy. Janssen Research & Development LLC sought approval of rivaroxaban at a proposed dose of 2.5 mg twice daily (BID) for a 90-day treatment duration.
