Bridion sugammadex regulatory update

Merck said it received a complete response letter from FDA for a resubmitted NDA 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's letter raised concerns about "operational aspects" of a hypersensitivity study requested by the agency in a 2008 not approvable letter. Merck said it is evaluating the letter and will work with the agency to determine a path forward in "the very near future," but declined to disclose details (see BioCentury, Aug. 4, 2008). ...