U.S. FDA Issues Action Letter For Sugammadex

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 02 Aug 2008 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Schering-Plough Corporation (NYSE: SGP) 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 biopharmaceutical 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 http://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.

Schering Plough Corporation
http://www.schering-plough.com