Bayer's anticoagulant rivaroxaban submitted for approval in US

Published: 1-Aug-2008
Regulatory

Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for rivaroxaban (Xarelto), a novel anticoagulant taken as one tablet, once-daily.


Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for rivaroxaban (Xarelto), a novel anticoagulant taken as one tablet, once-daily.

The application seeks approval for the use of rivaroxaban in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Rivaroxaban was invented in Bayer's Wuppertal laboratories and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Once marketing authorization has been granted in the US, rivaroxaban will be commercialised by Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Rivaroxaban was recommended for approval in Europe on July 24, this year for the prevention of venous thromboembolism (VTE) following elective hip and knee replacement surgery.

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