Merck Announces FDA Acceptance Of Resubmission Of New Drug Application 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.

In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity (allergic) reactions and coagulation (bleeding) events. Merck submitted this requested data within the NDA resubmission, which the FDA has now deemed complete for review.

“We are pleased the FDA has accepted our resubmission of sugammadex sodium injection for review, as this was a key milestone in our effort to bring this medicine to the U.S.,” said Darryle D. Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories. “Sugammadex sodium injection is an example of Merck’s ongoing commitment to developing new medicines for patients in hospital-based settings.”

Indication for ZEMURON ^® (rocuronium bromide) Injection

ZEMURON Injection, from Merck, is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Important safety information about ZEMURON

ZEMURON is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.

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