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【drug-news】美国FDA拒绝批准Schering-Plough的Bridion（
KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.
"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions." There were no issues related to the efficacy of sugammadex.
Schering-Plough acquired sugammadex in November 2007 through its acquisition of Organon BioSciences, which developed the product.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own ***aceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to Earn Trust, Every Day with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for sugammadex. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in the company's first quarter 2008 10-Q.
SOURCE Schering-Plough Corporation 本人认领该文献的翻译。如在24小时内没有翻译完，请其它站友继续认领。 美国FDA出乎意料地拒绝批准Schering-Plough的Bridion（sugammadex）
KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.
先令-普劳公司（纽交所：SGP）今天发表声明，美国FDA已对sugammadex sodium注射液下发“不批准”函，sugammadex sodium用于逆转全麻状态下的肌肉松弛。
"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions." There were no issues related to the efficacy of sugammadex.
“我们对此感到惊讶和失望，尤其是sugammade在今年3月份获得了FDA麻醉和生命保障咨询委员会一致推荐”， 先令-普劳的执行副总裁兼研究所总裁，Thomas P. Koestler博士说，“sugammadex代表了近二十年来麻醉领域出现的第一个重要的创新药。我们仍然致力于把这一重要的医学进步提供给那些期待它的美国人，并计划和代理处理此事，此事主要与过敏反应有关。”此事与sugammadex的有效性无关。
Schering-Plough acquired sugammadex in November 2007 through its acquisition of Organon BioSciences, which developed the product.
先令-普劳于2007年11月从Organon BioSciences获得sugammadex这个产品，Organon BioSciences研发了该产品。
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作者:admin@医学,生命科学 2011-06-09 16:03
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