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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 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.

  2. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

    In this briefing document, AstraZeneca will provide the information necessary to make an assessment of the benefit-risk profile for ximelagatran as an oral anticoagulant and antithrombotic based on comparisons of ximelagatran to warfarin and to placebo.

  3. www.fda.gov › safety › recalls-market-withdrawals-safety-alertsIndustry Guidance For Recalls | FDA

    1 Οκτ 2024 · Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff. Industry Recall Guidance: Product Recalls, Including Removals and Corrections ...

  4. www.fda.gov › medical-devices › postmarket-requirements-devicesRecalls, Corrections and Removals (Devices) | FDA

    A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed. 21 CFR 7 sets forth specific recall procedures for FDA to...

  5. www.fda.gov › safety › recallsRecalls, Market Withdrawals, & Safety Alerts | FDA

    1 Οκτ 2024 · Recalls, Market Withdrawals, & Safety Alerts. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not...

  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.sciencedirect.com › science › articleThe continuing challenge of drug recalls: Insights from a...

    15 Οκτ 2024 · In this study we analyzed drug recall data from the U.S. Food and Drug Administration (FDA) over the period 2012–2023. We identified trends in the number of recalls initiated annually and their underlying causes. On average, 330 drug recalls are initiated each year, showing an overall increasing trend.

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