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The approval of the oral anticoagulant rivaroxaban is on hold while the manufacturer evaluates a “complete response” letter issued by the Food and Drug Administration, according to the manufacturer, Ortho-McNeil.
The FDA has requested more information about rivaroxaban, which is under review for the prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery. A statement issued by the company said that Ortho-McNeil was evaluating the FDA's letter, and would address the questions raised as soon as possible. The FDA has not requested that any new clinical or nonclinical studies of safety and efficacy, according to the statement, which did not provide further details.
If approved, rivaroxaban, a direct Factor Xa inhibitor, would be the first oral anticoagulant approved for the two indications under review, and the first approved since warfarin. The FDA does not comment on products that are under review for approval.
The agency issues a complete response letter to a company when the review of a product approval application has been completed and the product cannot be approved based on available information. This has replaced the “approvable” and “nonapprovable” letters that the FDA previously issued.
In March, the majority of the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed that data from four clinical trials showed that the anticoagulant had a favorable risk-benefit profile for the proposed indications. Panel members were concerned about off-label use of the drug, and about the possibility that it might be used for longer periods than the duration studied in hip replacement patients (35 days) and knee replacement patients (14 days). Although the majority agreed that the potential hepatotoxicity of the drug should not preclude approval, the panel agreed that long-term data on the hepatotoxicity risk were needed (HOSPITALIST NEWS, April 2009, p. 1).
Ortho-McNeil is a division of Johnson & Johnson Pharmaceutical Research & Development LLC.
The approval of the oral anticoagulant rivaroxaban is on hold while the manufacturer evaluates a “complete response” letter issued by the Food and Drug Administration, according to the manufacturer, Ortho-McNeil.
The FDA has requested more information about rivaroxaban, which is under review for the prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery. A statement issued by the company said that Ortho-McNeil was evaluating the FDA's letter, and would address the questions raised as soon as possible. The FDA has not requested that any new clinical or nonclinical studies of safety and efficacy, according to the statement, which did not provide further details.
If approved, rivaroxaban, a direct Factor Xa inhibitor, would be the first oral anticoagulant approved for the two indications under review, and the first approved since warfarin. The FDA does not comment on products that are under review for approval.
The agency issues a complete response letter to a company when the review of a product approval application has been completed and the product cannot be approved based on available information. This has replaced the “approvable” and “nonapprovable” letters that the FDA previously issued.
In March, the majority of the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed that data from four clinical trials showed that the anticoagulant had a favorable risk-benefit profile for the proposed indications. Panel members were concerned about off-label use of the drug, and about the possibility that it might be used for longer periods than the duration studied in hip replacement patients (35 days) and knee replacement patients (14 days). Although the majority agreed that the potential hepatotoxicity of the drug should not preclude approval, the panel agreed that long-term data on the hepatotoxicity risk were needed (HOSPITALIST NEWS, April 2009, p. 1).
Ortho-McNeil is a division of Johnson & Johnson Pharmaceutical Research & Development LLC.
The approval of the oral anticoagulant rivaroxaban is on hold while the manufacturer evaluates a “complete response” letter issued by the Food and Drug Administration, according to the manufacturer, Ortho-McNeil.
The FDA has requested more information about rivaroxaban, which is under review for the prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery. A statement issued by the company said that Ortho-McNeil was evaluating the FDA's letter, and would address the questions raised as soon as possible. The FDA has not requested that any new clinical or nonclinical studies of safety and efficacy, according to the statement, which did not provide further details.
If approved, rivaroxaban, a direct Factor Xa inhibitor, would be the first oral anticoagulant approved for the two indications under review, and the first approved since warfarin. The FDA does not comment on products that are under review for approval.
The agency issues a complete response letter to a company when the review of a product approval application has been completed and the product cannot be approved based on available information. This has replaced the “approvable” and “nonapprovable” letters that the FDA previously issued.
In March, the majority of the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed that data from four clinical trials showed that the anticoagulant had a favorable risk-benefit profile for the proposed indications. Panel members were concerned about off-label use of the drug, and about the possibility that it might be used for longer periods than the duration studied in hip replacement patients (35 days) and knee replacement patients (14 days). Although the majority agreed that the potential hepatotoxicity of the drug should not preclude approval, the panel agreed that long-term data on the hepatotoxicity risk were needed (HOSPITALIST NEWS, April 2009, p. 1).
Ortho-McNeil is a division of Johnson & Johnson Pharmaceutical Research & Development LLC.