Baxter Promotional eMail Gets FDA Untitled Reply

Christopher Hollis

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Baxter Promotional eMail Gets FDA Untitled Reply

机译：百特促销电子邮件获得FDA无标题回复

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Baxter Healthcare's Feiba VH, a hemophilia therapy, is misbranded because the company disseminated a "clinical thank you email" that made misleading safety and efficacy claims, according to an FDA untitled letter. The July 7 letter, posted last week on the agency's website, was issued by the Division of Case Management in CBER's Office of Compliance and Biologies Quality. It requests that Baxter stop using the email and any similar communications. Feiba VH (anti-inhibitor coagulant complex, vapor-heated) is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. The biologic is a freeze-dried sterile human plasma component with Factor VIII inhibitor bypassing activity.

机译：根据FDA一封无标题的信函，百特医疗的血友病疗法Feiba VH被贴错了商标，因为该公司散布了“临床感谢邮件”，使人对安全性和功效产生误导。上周在该机构网站上发布的7月7日的信函是由CBER合规性和生物质量办公室的案例管理部发布的。它要求Baxter停止使用电子邮件和任何类似的通信。 Feiba VH（抗抑制剂凝结复合物，蒸气加热）适用于控制自发性出血发作或涵盖使用抑制剂治疗血友病A和血友病B的患者的外科手术。生物制剂是具有因子VIII抑制剂旁路活性的冻干无菌人血浆组分。

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《Washington Drug Letter》 |2008年第30期|p.11|共1页
作者
Christopher Hollis;
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Baxter Promotional eMail Gets FDA Untitled Reply

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