Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development has submitted a new drug application to the FDA for rivaroxaban, a novel anticoagulant taken as one tablet, once-daily.
Subscribe to our email newsletter
The new drug application (NDA) 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. Once marketing authorization has been granted in the US, rivaroxaban will be commercialized by Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals.
Rivaroxaban is said to be the first oral anticoagulant to demonstrate superior efficacy over the US approved twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approval, rivaroxaban is expected to become the first novel oral anticoagulant introduced in the US market for more than 50 years.