FDA Cancels Sugammadex Meeting, Merck Cites Trial Site Inspection

The FDA abruptly cancelled the July 18 meeting of its Anesthetic and Analgesic Drug Products Advisory Committee that was originally scheduled to discuss Merck’s NDA for sugammadex sodium injection. The agency declined to provide an explanation, but the drugmaker said the agency needed more time to assess inspection results from one of four sites where hypersensitivity studies were taking place.
Washington Drug Letter