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  1. www.fdatracker.com › fda-calendarFDA Calendar – FDA Tracker

    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.

    • Trial Tracker

      Trial Tracker Demo. This limited demo only displays Phase 3...

  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. 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

  4. 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 ...

  5. www.fda.gov › drugs › novel-drug-approvals-fdaNovel Drug Approvals for 2024 | FDA

    29 Ιουλ 2024 · FDA Novel Drug Therapy Approvals for 2024. The table below is a running list of CDER’s novel drugs approvals for 2024. Export Excel. Showing 1 to 23 of 23 entries. *The listed “FDA-approved...

  6. 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.

  7. www.pharmavoice.com › news › fda-pdufa-approval-dates-watch-2024-crispr4 big FDA approval dates to watch in 2024 - PharmaVoice

    12 Ιαν 2024 · This follows a year in which the FDA approved 55 new drugs, including several firsts, like the first vaccine against RSV and the first oral medication for postpartum depression. Here are four PDUFA dates to watch in 2024.

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