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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...
- 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.
12 Σεπ 2004 · Although the US Food and Drug Administration advisory panel reviewingAstraZeneca's Exanta (ximelagatran) had yet to meet (the hearing is scheduled for 13.30 UK time on September 10), the company's share priced moved lower on September 9, as panel documents on the drug were released indicating concerns on the safety and efficacy of the drug.
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 ...
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 ...
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 ...
News & Events. FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public. Topic Paragraphs. Newsroom. Press releases and...
