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1. 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.

2. 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...

3. www.fda.gov › drugs › drug-safety-and-availabilityFDA Updates and Press Announcements on NDMA in Zantac...

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

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   FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since 2018.

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

   datadashboard.fda.gov › ora › cd

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   The dataset is updated weekly and only includes recalls that have been classified. If you need to present more recent or more complete data for official purposes or have questions about obtaining...

5. www.fda.gov › medical-devices › postmarket-requirements-devicesRecalls, Corrections and Removals (Devices) | FDA

   www.fda.gov › medical-devices › postmarket-requirements-devices

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   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...

6. 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.

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 ...