Rivaroxaban for ACS Denied

The FDA advisory committee yesterday, January 16, 2013, unanimously withheld clearance for rivaroxaban’s acute coronary syndrome indication. Details appear in today’sMedscape Oncology Heartwire headline. This is the third time that Janssen’s application has been denied for this indication. Rivaroxaban is cleared for stroke  prevention in atrial fibrillation, thrombosis prevention following total hip or knee replacement surgery, and treatment following venous thromboembolism.