The FDA will also require that patients getting the drug receive a Medication Guide describing the risks and adverse reactions associated with the drug.The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic.Consumer information about rivaroxaban (Xarelto), a drug prescribed to prevent or treat AFib, DVT, and pulmonary embolism.Here is the FDA press release: FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
FDA: Approved Drugs: Questions and Answers The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.F ibrillation) global clinical trial, in which once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin.
By the time of its completion, more than 75,000 patients will have participated in the rivaroxaban clinical development program.
Summary: The FDA has approved a second alternative to warfarin, Xarelto (rivaroxaban), for stroke prevention in atrial fibrillation.Please note: This article was published more than one year ago.Since being approved in 2011, the anticoagulant has been subject to much Litigation.Bayer Healthcare (OTCPK:BAYRY) has launched its new anti-clotting drug Xarelto (rivaroxaban) in China following SFDA approval.
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