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

   www.fda.gov › safety › recalls

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   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 ...

   • Enforcement Reports

     Separate from determining whether a firm’s action meets the...

   • Industry Guidance For Recalls

     The .gov means it’s official. Federal government websites...

   • Major Product Recalls

     Recalls associated with Almark’s recall of hard-boiled egg...

   • Archive for Recalls, Market Withdrawals & Safety Alerts

     The Recalls, Market Withdrawals & Safety Alerts are...

2. www.nytimes.com › 2024/03/29 › healthFDA Issues Alert on Heart Pump Linked to Deaths - The New York...

   www.nytimes.com › 2024/03/29 › health

   29 Μαρ 2024 · March 29, 2024. A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to...

3. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

   s3-us-west-2.amazonaws.com › drugbank › cite_this

   EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 5 nonvalvular AF. SPORTIF III (SH-TPA-0003) was open-label and SPORTIF V (SH-TPA-0005) was double-blind; both had a single independent Adjudication Committee that completed blinded adjudication of all endpoint events. The primary endpoint of the

4. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

   www.drugs.com › history › exanta

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   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. en.wikipedia.org › wiki › XimelagatranXimelagatran - Wikipedia

   en.wikipedia.org › wiki › Ximelagatran

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   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.

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

   www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8

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   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 ...

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

   www.fda.gov › drugs › news-events-human-drugs

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   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 ...