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Safety First: FDA Rejects Schering-Plough Anesthesia Reverser
Posted on August 01, 2008
In a surprise, the FDA has rejected Schering-Plough s application to sell a drug called sugammadex, the company said. Even in today s tough safety climate, the thumbs-down is unusual because it goes against the unanimous recommendation of outside experts to the agency that it approve the drug, the first of its kind.The drug, which would be sold under the brand name Bridion, helps surgical patients recover more quickly from anesthesia. It would be the first drug in its class. The rejection was tied to hypersensitivity/allergic reactions associated with the drug, not to questions of ef...
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