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  1. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

    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 ...

  2. en.wikipedia.org › wiki › XimelagatranXimelagatran - Wikipedia

    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.

  3. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

    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 ...

  4. drugs.ncats.io › drug › ximelagatranXIMELAGATRAN - National Center for Advancing Translational...

    Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.

  5. www.ncbi.nlm.nih.gov › pmc › articlesXimelagatran (Exanta): alternative to warfarin? - PMC

    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 ( ).

  6. www.clinicaltrialsarena.com › projects › exantaExanta – Oral Direct Thrombin Inhibitor for the

    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.

  7. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

    EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 2 EXECUTIVE SUMMARY New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests 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