FDA: Concerns Remain for Merck’s Sugammadex

Merck announced today that the company has received a Complete Response Letter from the FDA for the resubmission of the New Drug Application (NDA) for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium (Zemuron; Merck) or vecuronium.

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In 2008, the FDA did not approve the original NDA, requesting additional data related to hypersensitivity reactions and coagulation events, which Merck submitted within the NDA resubmission. The FDA’s letter included concerns about operational aspects of that specific hypersensitivity study.

Sugammadex is designed to work by inactivating rocuronium or vecuronium molecules directly by encapsulation. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the U.S.

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