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Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin [1] that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.
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 ...
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 (Exanta), the first available oral direct thrombin inhibitor, and its active form, melagatran, have been evaluated in the prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement.
Ximelagatran is the first oral treatment in a new World Health Organization class of direct thrombin inhibitors and is the first new oral anticoagulant since the introduction of warfarin almost 60 years ago ( ). It was submitted to the Food and Drug Administration (FDA) for approval in December 2003 ( ).
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.
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 .
