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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 ...
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.
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 ημέρες πριν · In this review article, we highlight a discussion with Rakesh Jain, MD, MPH, regarding once-daily clonidine hydrochloride (ONYDA XR) for ADHD. We also highlight GLP-1 treatment for obesity and the associated lower suicidal ideation risk among adolescents with obesity, plus details on a recent recall of certain baby powder. Scroll below for more.
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.
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.
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.
