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approval for the use of EXANTA® (ximelagatran) Tablets as: œ An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute
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New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute VTE An oral 36-mg bid fixed dose ...
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.
25 Ιουν 2003 · Exanta (ximelagatran) is an oral direct thrombin inhibitor developed by AstraZeneca. It is indicated for the prevention and treatment of venous thromboembolism (VTE) and potentially for the prevention of stroke in patients with atrial fibrillation.
Ximelagatran was approved in France in December 2003 for preventing stroke in atrial fibrillation and for primary/secondary prevention of VTE in orthopaedic surgery. It was approved in the European Union in May 2004 for the latter indication.
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 ...
