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EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Gastrointestinal and Coagulation Drug Products has requested that AstraZeneca participate in a Cardiovascular and Renal Drugs Advisory Committee review of this application.
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FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation. Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial fibrillation, for the prevention ...
9 Φεβ 2005 · Full Text. Vitamin K (“Koagulation”) antagonists have been the sole oral anticoagulants available for 60 years, ever since Link 1 identified the components in spoiled sweet clover responsible for bleeding in cattle.
29 Οκτ 2024 · Dr. Elder: Yes. A class I recall is the most serious, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious adverse health consequences for a ...
It was on the background of these three concerns, but in particular that related to potential hepatotoxicity, that the US Federal Cardiovascular and Renal Drugs Advisory Committee to the Food and Drug Administration (FDA) recommended against approval of ximelagatran . This recommendation was applied to all three application indications for ...
