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FDA cancels sugammadex meeting

July 16, 2013 11:51 PM UTC

FDA canceled Thursday's meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss a resubmitted NDA from Merck & Co. Inc. (NYSE:MRK) for sugammadex for the reversal of neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium, which are given as part of general anesthesia to relax a patient's muscles during surgery. According to Merck, FDA said it needed additional time to assess a recently completed inspection of one of four clinical trial sites that conducted a hypersensitivity study requested by the agency. ...