Merck 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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