Merck Receives FDA Acceptance of Resubmission of NDA for Sugammadex Sodium Injection
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA's review to be completed in the first half of 2013.
Sugammadex sodium injection is the company's investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium (neuromuscular blocking agents). NMB is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by inactivating rocuronium or vecuronium molecules directly by encapsulation. If approved, it would be the first in a new class of medicines in the U.S. known as selective relaxant binding agents to be used in the surgical setting.
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