8月15日消息--环球医学据悉，美国卫生监管部门把对实验性肠道药物申请上市许可的审查日期推了迟三个月。

制药商在一份声明中说，美国食品和药物管理局目前已决定于2012年12月30日批准Gattex。

NPS制药公司表示，FDA延长日期，是为了提供时间全面审查于2012年1月提交的申请。

总部位于新泽西州的Bedminster公司已申请批准销售Gattex以治疗短肠综合症，这是一种由于丢失或手术切除部分小肠，导致身体无法合理吸收营养的疾病。

NPS制药公司的合作伙伴Nycomed，武田药品有限公司的子单位，目前正寻求欧洲对该药物的批准。

该公司的股份，到目前为止已经增长了约9％，周五纳斯达克股市收盘时为7.18美元。（环球医学）

原文

FDA extends review time for Pharma's bowel drug by three months

(Reuters) - NPS Pharmaceuticals Inc said U.S. health regulators pushed back the review date for the marketing approval application for its experimental bowel drug by three months.
U.S. Food and Drug Administration will now decide on the approval of Gattex on December 30, 2012, the drugmaker said in a statement.
The FDA extended the date to provide time for a full review of the submission, NPS Pharmaceuticals said. The application was accepted by the agency in January 2012.
The Bedminster, New Jersey-based company had applied for marketing approval of Gattex to treat short bowel syndrome, a condition where the body cannot absorb nutrients properly because a part of the small intestine is missing or surgically removed.
NPS Pharma's partner Nycomed, a Takeda Pharmaceutical Co Ltd unit, is currently seeking approval of the drug in Europe.
The company's shares, which have gained about 9 percent so far this year, closed at $7.18 on Friday on the Nasdaq.

相关链接：http://www.reuters.com/article/2012/08/13/us-npspharmaceutical-fda-boweldrug-idUSBRE87C0JW20120813

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