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FDA approves Xarelto for DVT and PE

November 3, 2012 1:08 AM UTC

FDA approved an sNDA from Johnson & Johnson (NYSE:JNJ) for Xarelto rivaroxaban to treat deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE. The oral Factor Xa inhibitor is approved in the U.S. to treat DVT and PE in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). J&J has U.S. rights to rivaroxaban from Bayer AG (Xetra:BAYN). ...