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FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Date:3/11/2008

Committee Recommends FDA Approve Novel Anesthesia Drug to Reverse Muscle

relaxation within Minutes

KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) Advisory Committee on Anesthetics and Life Support has recommended sugammadex for approval. After reviewing data on the safety and efficacy of the medication, the committee unanimously recommended approval of the company's application for marketing.

The FDA is not bound by the committee's recommendations; however, they usually are considered carefully before a final decision on approval is made.

Upon FDA approval, sugammadex will be the first and only selective relaxant binding agent (SRBA) and will give anesthesiologists the ability to rapidly and predictably reverse any depth of muscle relaxation induced by rocuronium and vecuronium within minutes. Sugammadex allows for flexible dosing of muscle relaxation agents enabling anesthesiologists to maintain optimal block through the end of the procedure.

"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the data on sugammadex," said Robert J. Spiegel, M.D., Chief Medical Officer and Senior Vice President, Schering-Plough Research Institute. "Sugammadex has the potential to transform the practice of anesthesia through improved management of muscle relaxation in the millions of surgeries where these agents are used. We will continue to work with FDA to bring sugammadex to the U.S. market as soon as possible so that anesthesiologists and their patients can benefit from this innovative product."

Earlier this year, Scherin
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SOURCE Schering-Plough
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