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标题: 美国谢绝通过先灵葆雅公司精神分裂症药物 [打印本页]

作者: woodmqf 时间: 09-2-7 22:59
标题: 美国谢绝通过先灵葆雅公司精神分裂症药物
美国谢绝通过先灵葆雅公司精神分裂症药物

纽约（路透社）1月14日— 周三，制药商宣布美国健康监管人员已经谢绝核准先灵葆雅公司治疗精神分裂症和双相情感障碍的实验药物，认为仍需要更多数据。

但是，美国食品与药品管理局（FDA）完整的意向函并未要求更多药物的临床试验。Saphris被提议为此药物的药品标签。先灵葆雅预期在一季度提供销售商需求的信息。
Saphris，也叫做阿塞那平，是先灵葆雅在11月投资见面会上主打的五个研发线之一。据预测，Saphris的销售将超过一年十亿美元。

“我们对Saphris的备案过程很满意，期望与经销商合作发布请求，确定商标名并通过认可。”先灵葆雅研究所所长Thomas Koestler在声明中指出。

先灵葆雅公司，2007年收购欧加农生物技术公司，从而获得阿塞那平。
US Declines to Clear Schering Schizophrenia Drug

NEW YORK (Reuters) Jan 14 - U.S. health regulators have declined to approve Schering-Plough Corp's experimental drug for schizophrenia and bipolar disorder, requesting more data, the drugmaker said on Wednesday.
But the U.S. Food and Drug Administration's complete response letter did not request additional clinical trials for the drug, Saphris, and included proposed product labeling for the medicine. Schering-Plough expects to provide the requested information to the agency in the first quarter.
Saphris, also called asenapine, was touted by Schering-Plough as one of five "stars" of its research pipeline at its investor meeting in November. It has forecast that Saphris sales could exceed $1 billion a year.
"We are pleased with the progress on the Saphris filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval," Thomas Koestler, president of the Schering-Plough Research Institute, said in a statement.
Schering-Plough gained asenapine through its 2007 acquisition of Organon BioSciences.

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