Resubmitted NDA Accepted for Sugammadex Sodium Injection for Reversal of Neuromuscular Blockade
Merck announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the FDA; sugammadex sodium injection is the company's investigational agent for the reversal of neuromuscular blockade induced by rocuronium (Zemuron; Merck) or vecuronium. 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 known as selective relaxant binding agents to be used in the surgical setting.
In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity reactions and coagulation events. Merck submitted this requested data within the NDA resubmission, which the FDA has now deemed complete for review. Merck expects the FDA's review to be completed in the first half of 2013.
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