Background Analysis: US FDA Advisory Committee to Review Merck’s Bridion for Selective Reversal of Neuromuscular Blockage – MAR 18, 2015 (AADPAC)
The US FDA has scheduled an Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) Meeting for Wednesday, March 18, 2015 to discuss new drug application (NDA) 022225, sugammadex sodium injection (trade name Bridion), 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 (known as MDS outside of the U.S. and Canada).