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ARTICLE | Company News

EU approves Xarelto label expansion

May 25, 2013 12:53 AM UTC

Bayer AG (Xetra:BAYN) said the European Commission approved a label expansion for 2.5 mg twice-daily Xarelto rivaroxaban to include the prevention of atherothrombotic events in combination with standard antiplatelet therapy after acute coronary syndrome (ACS) in adults with elevated cardiac biomarkers. In March, FDA issued a second complete response letter for an sNDA from the Janssen Research & Development LLC unit of U.S. partner Johnson & Johnson (NYSE:JNJ) seeking to expand Xarelto's label to include the reduction of the risk of cardiovascular events in ACS patients. ...