Two drugs containing omeprazole recalled— both lacked FDA approval

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Two drugs containing omeprazole recalled— both lacked FDA approval

机译：召回两种含有奥美拉唑的药物-均未获得FDA批准

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Over-the-counter drugs Gastrotec and Gastroade Xtra have been pulled from the market; production ceased.Gastrotec, a product labeled for the care of gastric and colonic ulcers in horses, has been recalled. Previously marketed by Tri-star Equine Marketing as an over-the-counter drug containing omeprazole and misoprostol, the drug was voluntarily recalled after the U.S. Food and Drug Administration (FDA) alerted the company that its distribution of the product was illegal without an approved new animal drug application. Thus, a recall and halt to all production and sales of Gastrotec will be in effect in the United States until approval by the FDA is obtained.

机译：非处方药Gastrotec和Gastroade Xtra已被撤出市场。停产。召回了Gastrotec，该产品被标记为用于治疗马的胃和结肠溃疡。先前由Tri-star Equine Marketing作为含有奥美拉唑和米索前列醇的非处方药销售，该药物在美国食品药品监督管理局（FDA）通知该公司未经授权而未经授权散布该产品后被自愿召回。新的动物药应用。因此，在美国，直到获得FDA的批准，Gastrotec的所有生产和销售都将被召回和停止。

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《DVM360》 |2015年第3期|共1页
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正文语种 eng
中图分类动物医学（兽医学）;
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1. Two drugs containing omeprazole recalled— both lacked FDA approval [J] . DVM360 . 2015,第3期

机译：召回两种含有奥美拉唑的药物-均未获得FDA批准
2. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第8期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理批准的新剂型和适应症，待FDA批准的新药物/生物学许可由制造商提交的重要标签变更或与安全相关的“亲爱的健康专业人员”信函
3. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2010,第6期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理商批准的新剂型和适应症，待FDA批准的制造商提出的新药/生物许可申请，制造商提出的补充申请，重要的标签变更或与“亲爱的健康专业人员”的信件安全
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. Meta-Analysis to Identify and Evaluate Factors Associated with Regulatory Approval of Orphan Drugs (OD) to Develop an Algorithm for Predicting Regulatory Approval (Success) and to Develop a Standardized Tool to Improve Orphan Drug Portfolio Decision-Making [D] . Florent, Milky C. 2019

机译：荟萃分析，以识别和评估与孤儿药物监管批准（OD）相关的因素，以开发预测监管批准（成功）的算法，并开发标准化工具以改善孤儿药物投资组合决策
6. ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials [O] . Lisa M. Schwartz, Steven Woloshin, Eugene Zheng, -1

机译：ClinicalTrials.gov和Drugs @ FDA：新药批准试验的结果报告比较
7. Drugs, Devices, and the FDA: Part 2 An Overview of Approval Processes: FDA Approval of Medical Devices [O] . Van Norman Gail A. 2016

机译：药品，器械和FDA：第2部分批准过程概述：FDA批准医疗器械

Two drugs containing omeprazole recalled— both lacked FDA approval

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