Bridion sugammadex regulatory update

FDA cancelled the March 18 meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss Merck’s sugammadex to reverse neuromuscular blockade due to muscle relaxants rocuronium or vecuronium. The company expects to receive a complete response letter from FDA for its resubmitted NDA for the compound, which has an April 22 PDUFA date. The company said FDA plans to conduct “additional site inspections related to a hypersensitivity study.” ...