www.fdanews.com/articles/115584-fda-panel-recommends-approval-of-j-38-j-8217-s-rivaroxaban
FDA Panel Recommends Approval of J&J’s Rivaroxaban
March 20, 2009
An FDA advisory panel recommended that benefits of Johnson & Johnson’s (J&J) rivaroxaban anticoagulant — which studies have shown is more effective than Sanofi-Aventis’ Lovenox — outweigh its risk of liver damage and bleeding. The Cardiovascular and Renal Drugs Advisory Committee voted 15–2 to recommend that the FDA approve rivaroxaban 10 mg to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Drug Industry Daily
Drug Industry Daily