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  1. 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

  2. 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 ...

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

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

  4. 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.

  5. www.fda.gov › about-fda › histories-fda-regulated-productsSummary of NDA Approvals & Receipts, 1938 to the present

    * Data through 1976 are reported for the fiscal year, 1 July through 30 June; data thereafter are reported for the calendar year. It is unknown if the de Haen data are based on calendar or fiscal...

  6. www.fda.gov › drugs › nda-and-bla-approvalsNDA and BLA Calendar Year Approvals | FDA

    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 ...

  7. 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.

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