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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
7-4 - Recall Letter; 7-5 - Recall Return Response Form; 7-6...
- 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...
- Enforcement Reports
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.
Exanta FDA Approval Status. 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 ...
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.
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 ...
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...
FDA news roundup. Food and Drug Administration stories include proposed changes to nutrition fact labels, the safety of the pharmaceutical supply chain, regulating high blood pressure devices,...
