FDA issues Complete Response for sugammadex
Merck Inc., announced that the company has received a Complete Response Letter from the FDA for the resubmission of the New Drug Application for sugammadex sodium injection (known as Bridion in the EU), Merck�s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. The FDA�s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near future.
Bridion was EU approved on 29th July 2008.
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