Biotech Values

[DewDiligence]

FDA Rejects SGP’s Sugammadex, Overriding Advisory Panel

[Evidently, the FDA is paying less and less attention to advisory-panel voting. Perhaps the FDA should convene these panels for advice only and dispense with the formality of taking a (meaningless) vote.]

http://biz.yahoo.com/prnews/080801/nyf023.html

›FDA Issues Action Letter for Sugammadex

Friday August 1, 7:00 am ET

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.‹



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