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Bayer and J&JPRD submit rivaroxaban application in US
30 Jul 2008
Regulatory Affairs
Bayer has said its cooperative partner Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted the new drug application in the US for the anticoagulant rivaroxaban.
The companies are seeking approval for rivaroxaban - under the brand-name Xarelto - to be used in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Rivaroxaban was recently recommended for approval in Europe for the prevention of venous thromboembolism following elective hip and knee replacement surgery, with a final decision expected there within the coming months.
Dr Kemal Malik, member of the Bayer HealthCare Executive Committee who is responsible for product development, said: "Current standards of anticoagulation therapy have limitations and new preventative therapies are needed.
"We are now on the cusp of revolutionising the care of patients undergoing hip and knee replacement surgery."
Meanwhile, Bayer has just reported an "outstanding" performance by its CropScience subgroup in the last quarter, which saw an increase in sales of 15.5 per cent compared with the same period last year.
