ActionFDA Action Letter for SugammadexSchering-Plough Corporation announced that the U SAU.

ActionFDA Action Letter for SugammadexSchering-Plough Corporation announced that the U.S. Food and Drug Administration has a ‘non – approvable ‘letter for sugammadex sodium injection for the reversal of muscle relaxation during issued a general anesthetic SAU . ‘We are surprised and disappointed by this action, particularly as sugammadex, a unanimous recommendation for approval obtained by the FDA Advisory Committee on Anesthesia and Life Support in March of this year,’said Thomas P. Koestler, executive vice president and president of Schering-Plough Research Institute. ‘Sugammadex is the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to this important medical advance to those who are waiting for it in the United States, and to plan with the agency are working the issues the problems the primary hypersensitivity / allergic reactions associated. ‘There were no problems with regard to the efficacy of sugammadex.

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