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BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
Date:7/29/2008

uscle relaxants rocuronium bromide (ZEMURON(R)/ESMERON/ESLAX(R)) or vecuronium bromide (NORCURON/MUSCULAX(R)), which can give anesthesiologists greater control over muscle relaxation during surgery. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. BRIDION works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive, allowing patients to more rapidly regain muscle function after surgery and breathe on their own.

BRIDION is approved in the European Union (EU) for reversal of neuromuscular blockade induced by rocuronium or vecuronium. In children and adolescents, BRIDION is only recommended for routine reversal of rocuronium induced blockade.

In the United States, a New Drug Application (NDA) for sugammadex has been filed with the U.S. Food and Drug Administration (FDA) and assigned priority review status. The FDA Advisory Committee on Anesthetics and Life Support in March of this year unanimously recommended approval of sugammadex. In Japan, a New Drug Application seeking marketing approval of sugammadex has been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW) and is currently under review.

Schering-Plough acquired BRIDION (sugammadex) through its combination with Organon BioSciences in November 2007.

Important Safety Information About BRIDION

BRIDION (sugammadex) should only be administered by or under the supervision of an anesthesiologist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. The use of sugammadex in patients with severe renal impairment is not recommended.

In clinical trials, the most commonly reported adverse reaction was metal or bitter taste. Also commonly reported were anesthetic complications, indicative of the restoration of neuromuscular function, including movement of a limb or the body
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SOURCE Schering-Plough Corporation
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