Αποτελέσματα Αναζήτησης
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
Public Warning and Notification of Recalls Under 21 CFR Part...
- 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
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.
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.
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 ...
FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.
2 Οκτ 2024 · FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy: 4/20/2022
6 Απρ 2022 · The guidance follows two public meetings held by the FDA about device recalls and safety communications, where experts, patients and industry representatives talked about ways to improve a system that can, at times, rely on outdated processes and leave patients in the dark when devices fail.
