Briefing Summary: US FDA Posts Advisory Committee Materials for Merck’s Proposed Reversal Agent to Neuromuscular Blockage, Sugammadex – NOV 6, 2015 (AADPAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Friday, November 6, 2015 Anesthetic and Analgesic Drugs Advisory Committee (AADPAC). The committee will discuss new drug application (NDA) 022225 for sugammadex, submitted by Organon USA Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium. Since the NDA submission, Organon was acquired by Schering Plough, and Schering Plough merged with Merck Sharp & Dohme Corporation.
See the SAC Tracker report