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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.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 all ...

  3. datadashboard.fda.gov › ora › cdFDA Dashboards - Recalls - Food and Drug Administration

    Current recall data used in this Dashboard is based upon the Enforcement Reports. Only recalls classified on or after 06/08/2012 are displayed on the dashboard. For detailed information about...

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

    The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Gastrointestinal and Coagulation Drug Products has requested that AstraZeneca participate in a Cardiovascular and Renal Drugs Advisory Committee review of this application.

  5. 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.

  6. www.fda.gov › drugs › drug-safety-and-availabilityDrug Recalls | FDA - U.S. Food and Drug Administration

    FDA provides a searchable list of recalled products. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA...

  7. 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.

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