Bridion sugammadex regulatory update

FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet July 18 to discuss a resubmitted NDA from Merck 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. In March, FDA extended by 3 months its review of the resubmitted NDA (see BioCentury, March 25). Merck said it expects a decision next half, but the specific PDUFA date is not disclosed. The cyclodextrin derivative is approved as Bridion in the EU for reversal of rocuronium or vecuronium and in Japan to reverse neuromuscular block. ...