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

    1 Οκτ 2024 · The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.

  2. www.fda.gov › drugs › news-events-human-drugsUnderstanding Drug Recalls with Dr. Ileana Elder | FDA

    29 Οκτ 2024 · Dr. Elder: Yes. A class I recall is the most serious, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious adverse health consequences for a ...

  3. 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.

  4. 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.

  5. 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 ...

  6. www.contemporarypediatrics.com › view › weekly-review-baby-powder-recall-glp-1sWeekly review: Baby powder recall, GLP-1s, and talking ONYDA XR...

    3 ημέρες πριν · In a public service announcement, the FDA is sharing Dynarex Corporation's expanded recall of Dynacare Baby Powder, 4 oz and 14 oz because they have the potential to be contaminated with asbestos. Dynarex stated that the products were sent to distributors via direct deliver after January 18, 2024, to 35 states and Amazon.com.

  7. www.fda.gov › news-eventsNews & Events | FDA - U.S. Food and Drug Administration

    FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.

  1. Αναζητήσεις που σχετίζονται με exanta fda review and recall news today full episode written update

    exanta fda review and recall news today full episode written update video