Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection
Friday, March 13, 2015 4:02 pm EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Merck's investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review.
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Pamela Eisele, 267-305-3558
Justin Holko, 908-740-1879