FDA advisory panel again rejected rivaroxaban for ACS
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Last Update: 2014-01-17
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Source: Internet
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Author: User
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Source: dingxiangyuan 2014-01-17 FDA cardiovascular and renal Drugs Advisory Committee concluded on January 15 that the Johnson & Johnson anticoagulant rivaroxaban should not be approved for the prevention of acute coronary syndrome in patients with a history of heart attack The Advisory Committee voted almost unanimously (10-0, 1 abstention) to reject the application for the new indication of rivaroxaban Experts say the data from a single clinical trial is not enough for the drug to be approved, especially some clinical trial data are still missing Rivaroxaban has been approved for the treatment and prevention of deep vein thrombosis and pulmonary embolism, as well as for the reduction of the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation Source address: http://
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