July 02, 2013
ASA Supports New Drug Application for Sugammadex
In a formal comment letter to the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee, ASA expressed strong support for the approval of sugammadex. The proposed indications for use of sugammadex are the routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium, and the immediate reversal of NMB at 3 minutes after administration of rocuronium. The FDA Advisory Committee will meet on July 18 to discuss this New Drug Application (NDA), which was submitted by Organon USA Inc.
In support of the application, ASA stated that "sugammadex is a novel, unique drug that provides anesthesiologists [with] better capabilities to reverse moderate and deep NMB. It is not just a 'better' reversal agent, but one that provides a new paradigm for anesthesia care. Sugammadex will significantly enhance the ability of anesthesiologists to more safely care for patients and reduce the incidence of critical respiratory adverse events in the PACU, especially for patients most at risk."
ASA will continue to closely monitor FDA’s action on the sugammadex application.
Review ASA's formal support to the FDA for sugammadex.
Learn more about the FDA’s New Drug Application process.