Last June, an FDA panel of outside medical experts met to consider Geodon along with two other drugs for pediatric use.
去年六月,美国食品药品监督管理局组织外界医学专家就Geodon和其他两个药物用于青少年治疗进行了讨论。
The Food and Drug Administration has warned Pfizer Inc. of "significant violations" involving pediatric trials of its antipsychotic drug Geodon.
美国食品药品监督管理局已经警告辉瑞公司(Pfizer),称其安定药Geodon的青少年临床试验严重违规。
A Pfizer spokeswoman said the letter primarily related to one main study of Geodon that was conducted for bipolar disorder at 36 clinical sites.
一名辉瑞发言人称,警告信主要和一项在36个临床基地用Geodon治疗双重人格症的研究。
The settlement announcement said Pfizer also illegally promoted the anti-psychotic drug Geodon, the antibiotic Zyvox and the anti-epilepsy drug Lyrica.
这一公告还表示,辉瑞还非法地宣传了抗精神病药齐拉西酮(Geodon),抗生素利奈唑酮(Zyvox)以及抗癫痫药物普瑞巴林(Lyrica)。
Many panel members said they were concerned about the high number of patients who didn't complete clinical studies of Geodon, making its safety difficult to assess.
很多专家组成员称很多病人没有完成Geodon的临床试验,这使得药物安全性很难评价。
Many panel members said they were concerned about the high number of patients who didn't complete clinical studies of Geodon, making its safety difficult to assess.
很多专家组成员称很多病人没有完成Geodon的临床试验,这使得药物安全性很难评价。
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