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FDA Rejects Schering-Plough's Anaesthetic Drug Sugammadex NDA

www.medicalnewstoday.com

The U.S. FDA has issued a non-approvable letter to Schering-Plough regarding the U.S. firm's New Drug Application (NDA) for sugammadex sodium. The product (also marketed under the brand Bridion) is a selective relaxant binding agent that reverses the effects of neuromuscular blockade by rocuronium in general anaesthesia. In a press statement, Schering-Plough has said that the FDA's concerns over the drug are related to hypersensitivity or allergic reactions. No issues related to the efficacy of the drug have been mentioned by the agency.

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