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【drug-news】惠氏抗抑郁药 Pristiq 获 FDA 批准
By Ransdell Pierson
NEW YORK (Reuters) Mar 03 - Drugmaker Wyeth won U.S. approval to sell Pristiq to treat depression, the U.S. Food and Drug Administration said on Friday.
An FDA spokesperson confirmed the approval, but provided no other details.
Pristiq is a derivative of Wyeth's widely used Effexor antidepressant and the company had hoped it would be approved long before Effexor loses its U.S. patent protection in 2010 and faces generic competition.
Wyeth also has tested Pristiq as a treatment for hot flashes in post-menopausal women, but the FDA last summer said it could not approve the drug for that condition until Wyeth resolved concerns about potentially serious heart and liver problems. The company plans to begin a new study in coming months to verify its safety.
Wyeth in December said a low-dose 50-mg form of Pristiq was effective in two late-stage depression trials and far better tolerated than a 100-mg version that failed to win U.S. approval in early 2007.
The 100-mg version had proved ineffective in one of the phase III studies, tarnishing overall results of the two trials.
Wyeth submitted results last summer of the studies, one conducted in the United States and one conducted overseas, to the U.S. Food and Drug Administration.
In studies of the 100-mg dose of Pristiq conducted more than a year ago, a high percentage of patients complained of nausea and stopped taking the drug, creating doubts that doctors would prescribe it or patients take it even if it were approved.
Wyeth scrapped that formulation and began studies of the now-approved 50-mg pill, hoping it would not cause nausea. The percentage of patients who dropped out of the trials because of side effects was similar to those who received a placebo, indicating the lower dosage pill was tolerated.
The FDA in early 2007 refused to approve the 100-mg formulation, in part because of long-standing quality-control lapses at a Wyeth plant in Puerto Rico where Pristiq was to be manufactured. The problems have since been fixed and the 50-mg pill is manufactured there.
http://www.medscape.com/viewarticle/570926 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 这个东西要是真的有效且便宜就好了。 初次翻译，不当之处欢迎指正 creating doubts that doctors would prescribe it or patients take it even if it were approved.
因而引发了医师是否会开此药、患者是否会服此药甚至能否获得批准的猜疑。
以上翻译有问题吧
应该是
因而引发了这样的怀疑：即即使它被批准，医生是否会处方此药或者患者是否会服用此药。
The problems have since been fixed and the 50-mg pill is manufactured there.
FDA 在2007年早期拒绝批准100mg的剂型，一定程度上是因为制造Pristiq的惠氏公司波多黎各生产厂常年存在的质量控制上的缺陷。从那以后，这些问题也已确定，并且50mg的药丸也在那里生产。
应该是这些问题已经得到解决~~~~~ 很感谢rainjoy2006战友给出的翻译，吾以为以下两处这样翻译是不是会更好：
1.... the company had hoped it 多谢楼上两位战友指点 是否漏译了这一句：company plans to begin a new study in coming months to verify its safety.（接在“公司希望郁复伸于2010年失去美国专利保护面临通用名药竞争前获得批准”后面的“。
“另一试验不是在美国本土进行的”，为什么不直接译成“另一试验在海外进行”？ Pristiq is a derivative of Wyeth's widely used Effexor antidepressant and the company had hoped it would be approved long before Effexor loses its U.S. patent protection in 2010 and faces generic competition.
Pristiq是惠氏的另一抗抑郁药物Effexor（郁复伸）的衍生物，公司希望郁复伸于2010年失去美国专利保护面临通用名药竞争前获得批准。
Effexor的中文名是：宜诺思 确实是“怡诺思”
起初AHP公司进口中国申请行政保护时，商品名为“郁复伸”。
http://www.sfda.gov.cn/WS01/CL0077/11017.html
申请人：AHP制药有限公司
申请药品名称：通用名：维拉法辛(Venlafaxine)
商品名：郁复伸(Efexor)缓释胶囊
申请号：A－NL99041610
申请日：1999年4月16日
药品行政保护办公室对该药品的申请文件初步审查合格，予以受理，即日起转为实质审
查，特此公告。
国家药品监督管理局1999年5月4日
2002年3月，美国家庭用品公司(AHP)更名为惠氏(Wyeth)公司,意欲同其竞争对手默克和强生一争高下。
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作者:admin@医学,生命科学 2011-04-07 18:32
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