J&J Receives Complete Response on Xarelto for Acute Coronary Syndrome

The FDA has given Johnson & Johnson (J&J) a complete response letter for its sNDA on the blood-clot drug Xarelto following a narrow advisory committee rejection last month. J&J will work with the agency to address the questions but the complete response could delay sNDA approval by 12 months, Leerink Swann analyst Seamus Fernandez wrote in an investors note.
Drug Industry Daily