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  1. 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

  2. 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 ...

  3. 2 Μαρ 2023 · CDER Drug and Biologic Approvals for Calendar Year 2020. CDER Drug and Biologic Approvals for Calendar Year 2019. CDER Drug and Biologic Approvals for Calendar Year 2018. CDER Drug and Biologic ...

  4. Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.

  5. Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.

  6. www.fda.gov › development-approval-process-cber › biological-approvals-yearBiological Approvals by Year | FDA

    31 Ιουλ 2024 · A collection of biological approval information organized by year and regulatory authorities.

  7. 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.

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