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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.
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.
24 Οκτ 2024 · Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety Communication (Updated) August 2, 2024. COVID-19 Tests Granted Traditional Marketing Authorization by the...
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...
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 FDA...
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 ...
Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.
