BioCentury
ARTICLE | Clinical News

Bridion sugammadex regulatory update

May 4, 2015 7:00 AM UTC

FDA issued a complete response letter to Merck for an NDA for sugammadex to reverse neuromuscular blockade due to muscle relaxants rocuronium or vecuronium. Merck said FDA asked for additional sensitivity analyses regarding the data the pharma had submitted. Merck expects to respond to the agency “in the very near future.” Last month, FDA cancelled an advisory committee meeting to discuss sugammadex and Merck said it expected the agency to issue a complete response letter (see BioCentury, March 30). ...