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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
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 ...
Included with this letter of appeal for approval to change to KESIMPTA are relevant supporting medical documentation, including a letter of medical necessity, clinical trial information, and the US Food and Drug Administration (FDA) approval letter. I have also attached the original denial letter.
The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic...
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.
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 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 ...
