KENILWORTH, N.J., Aug. 1 Schering-PloughCorporation (NYSE: SGP) today announced that the U.S. Food and DrugAdministration (FDA) has issued a "not-approvable" letter for sugammadexsodium injection for the reversal of muscle relaxation during generalanesthesia.
"We are surprised and disappointed with this action, especially given thatsugammadex received a unanimous recommendation for approval by the FDAAdvisory Committee on Anesthetics and Life Support in March of this year,"said Thomas P. Koestler, Ph.D., executive vice president and president ofSchering-Plough Research Institute. "Sugammadex represents the first majorpharmaceutical innovation in the field of anesthesia in two decades. Weremain committed to bringing this important medical advance to those who arewaiting for it in the United States, and plan to work with the agency toaddress the issues, which are primarily related to hypersensitivity/allergicreactions." There were no issues related to the efficacy of sugammadex.
Schering-Plough acquired sugammadex in November 2007 through itsacquisition of Organon BioSciences, which developed the product.
Schering-Plough is an innovation-driven, science-centered global healthcare company. Through its own biopharmaceutical research and collaborationswith partners, Schering-Plough creates therapies that help save and improvelives around the world. The company applies its research-and-developmentplatform to human prescription and consumer products as well as to animalhealth products. Schering-Plough's vision is to Earn Trust, Every Day withthe doctors, patients, customers and other stakeholders served by itscolleagues around the world. The company is based in Kenilworth, N.J., andits Web site is www.schering-plough.com
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press releaseincludes certain "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995, including statementsrelating to the plans for, the potential of and the potential market forsugammadex. Forward-looking statements relate to expectations or forecasts offuture events. Schering-Plough does not assume the obligation to update anyforward-looking statement. Many factors could cause actual results to differmaterially from Schering-Plough's forward-looking statements, including theregulatory process, among other uncertainties. For further details aboutthese and other factors that may impact the forward-looking statements, seeSchering-Plough's Securities and Exchange Commission filings, including PartII, Item 1A, "Risk Factors" in the company's first quarter 2008 10-Q.
SOURCE Schering-Plough Corporation