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news.Bayer has received a complete response letter from the US Food and Drug Administration (FDA) for its new drug application (NDA), rivaroxaban. The new drug will be used for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.
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Earlier in July 2008, Bayer’s partner Johnson & Johnson filed for the approval to market Rivaroxaban. FDA has not requested any new clinical or non-clinical studies to be conducted for evaluating the efficacy or safety of Rivaroxaban, for this indication as a pre-requisite for approval.
However, Bayer is confident in the positive benefit-risk profile of Rivaroxaban, saying the questions raised by the FDA can be promptly addressed. Kemal Malik, Member of the Executive Committee and Chief Medical Officer at Bayer, said: “Together with our development partner, we are evaluating the letter and we will promptly address FDA’s questions.”
If approved by the FDA, Ortho McNeil, a division of Ortho McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company, will commercialize Rivaroxaban in the US and Bayer HealthCare will be responsible for the marketing of Rivaroxaban in countries outside the US.