J&J Submits NDA for Rivaroxaban

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, was co-developed with Bayer HealthCare AG. Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S., if it’s approved. Bayer holds marketing rights in countries outside the U.S. ...

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