FDA Issues Complete Response Letter for Ortho-McNeil Pharmaceutical, Inc.'s Rivaroxaban

Published: May 28, 2009

RARITAN, N.J.--(BUSINESS WIRE)--Ortho-McNeil announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for rivaroxaban, an oral, once-daily anticoagulant. The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.

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