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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 ...
Side effects. Ximelagatran was generally well tolerated in the trial populations, but a small proportion (5–6%) developed elevated liver enzyme levels, which prompted the FDA to reject an initial application for approval in 2004. The further development was discontinued in 2006 following reports of hepatotoxicity.
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.
Ximelagatran, a prodrug of melagatran, is an orally administered direct inhibitor of both free and clot-bound thrombin. It is rapidly absorbed and quickly converted to its active form, melagatran, with stable and reproducible pharmacokinetic properties.
9 Φεβ 2005 · 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.
The introduction of ximelagatran (Exanta®, AstraZeneca), as the first new class of OAC in over 50 years, and with its favorable pharmacokinetic and pharmacodynamic represented a major potential turning point in OAC therapy .
1 Φεβ 2005 · P. Shyamasakhi Devi. Kh. Sharatchandra. Request PDF | On Feb 1, 2005, Olga Hilas and others published Ximelagatran (Exanta™): A Product Review and Update | Find, read and cite all the research...
