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

    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. 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 ... -...

    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 ...

  4. 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 ...

  5. 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.

  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. www.fda.gov › tobacco-products › retail-sales-tobacco-productsThis is Our Watch | FDA - U.S. Food and Drug Administration

    29 Αυγ 2024 · FDA Age Calculator. Download the “FDA Age Calculator,” a voluntary smartphone application to help retailers comply with federal, state, and local age restrictions for selling tobacco...

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