Merck Inc re-files sugammadex at FDA
Merck Inc., has announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection ,(known as Bridion in Europe), has been accepted for review by the FDA. Merck expects the FDA�s review to be completed in the first half of 2013.
Sugammadex sodium injection is an 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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