September 23, 2013
FDA Rejects Sugammadex Application
On September 23, Merck Inc. announced it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) informing the company that its resubmitted New Drug Application for sugammadex had been rejected. According to Merck, the FDA raised issues with "operational aspects of a hypersensitivity study" that the FDA had requested in 2008.
ASA had previously expressed strong support for the approval of sugammadex in a formal comment letter to the FDA's Anesthetic and Analgesic Drug Products Advisory Committee. 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.
Review ASA's previous support.