FDA does not ask for new rivaroxaban trials
The US Food and Drug Administration has not requested any new clinical trials in its Complete Response letter to Bayer's New Drug Application for rivaroxaban, a novel, oral anticoagulant taken as a once-daily tablet.
In a statement, the German firm said it is confident in the positive benefit-risk profile of rivaroxaban and that the questions raised by the FDA can be promptly addressed.
The NDA, filed in July 2008 by Bayer's development partner, US health care major Johnson & Johnson, seeks approval to market rivaroxaban, a first-in-class direct Factor Xa inhibitor, for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
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