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  1. 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 ...

  2. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (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. This briefing document has been prepared to support that review.

  3. 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.

  4. 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...

  5. 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...

  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.ncbi.nlm.nih.gov › pmc › articlesXimelagatran (Exanta): alternative to warfarin? - PMC

    As of September 13, 2004, ximelagatran was deemed not approvable by the FDA Cardiovascular and Renal Drugs Advisory Committee. Collection of further data to support the approval of this potentially hepatotoxic oral direct thrombin inhibitor is recommended .

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