FDA panel rejects Janssen's Xarelto in ACS, again
This article was originally published in Scrip
Executive Summary
For the second time, an FDA panel of advisers said Janssen Research and Development lacks the data necessary to support approval of Xarelto (rivaroxaban) in combination with aspirin plus a thienopyridine as a therapy to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).