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Merck expects third FDA rejection for sugammadex

March 17, 2015 12:53 AM UTC

FDA canceled Wednesday's meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss sugammadex ( MK-8616) from Merck & Co. Inc. (NYSE:MRK). The company said it expects to receive a complete response letter from FDA for its resubmitted NDA for the compound, which has an April 22 PDUFA date.

Merck resubmitted the NDA in October 2014 for the reversal of neuromuscular blockade induced by the muscle relaxants rocuronium or vecuronium. The company said FDA plans to conduct "additional site inspections related to a hypersensitivity study." ...