KENILWORTH, N.J., January 17, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corporation announced that Nippon Organon K.K., now part of Schering-Plough, has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its novel selective relaxant binding agent (SRBA), sugammadex.
Sugammadex is specifically designed to rapidly reverse the effects of certain muscle relaxants, rocuronium bromide (marketed in the U.S. as ZEMURON(R) and in Japan as ESLAX(R)), as well as vecuronium bromide (marketed in Japan as MUSCULAX(R)). Muscle relaxants are used as part of general anesthesia during surgical procedures.
The company announced on January 2, 2008, that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the New Drug Application (NDA) filing for sugammadex. Additionally, the Marketing Authorization Application for sugammadex was accepted for review by the European Medicines Agency (EMEA) in July 2007.
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
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