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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

     Recall data in the Enforcement Report can be accessed...

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

   www.fda.gov › drugs › drug-safety-and-availability

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   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...

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 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.

4. www.fda.gov › safety › recalls-market-withdrawals-safety-alertsEnforcement Reports | FDA - U.S. Food and Drug Administration

   www.fda.gov › safety › recalls-market-withdrawals-safety-alerts

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   Recall data in the Enforcement Report can be accessed through the weekly report publication, the quick and advanced search functionalities, and an Application Programming Interface (API).

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

   www.drugs.com › history › exanta

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   Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.

6. www.clinicaltrialsarena.com › projects › exantaExanta – Oral Direct Thrombin Inhibitor for the

   www.clinicaltrialsarena.com › projects › exanta

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   25 Ιουν 2003 · Exanta (ximelagatran) is an oral direct thrombin inhibitor developed by AstraZeneca. It is indicated for the prevention and treatment of venous thromboembolism (VTE) and potentially for the prevention of stroke in patients with atrial fibrillation.

7. 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 ...