5:18 PM
Feb 14, 2014
 |  BC Extra  |  Company News

FDA again rejects label expansions for J&J's Xarelto

FDA issued complete response letters for a pair of sNDAs from Johnson & Johnson (NYSE:JNJ) seeking approval of Xarelto rivaroxaban to reduce the risk of thrombotic cardiovascular events and risk of stent thrombosis in combination with antiplatelet therapy in patients with acute coronary syndrome (ACS). J&J could not be reached for details on the contents of the letters. FDA...

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