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FDA to Review Anesthesia Recovery Drug
Merck resubmitted New Drug Application for sugammadex sodium injection.
Published:January 8, 2013
Sugammadex, Merck's experimental drug for reversing the effects of anesthesia after surgery, is back before the FDA.
Merck expects the FDA to complete the review within the next 6 months. This is Merck's second try to get the injected drug approved. The FDA rejected sugammadex in 2008 over concerns about allergic reactions and bleeding in some participants in clinical studies. If approved, sugammadex would be the first in a new class of medicines for reversing effects of certain drugs that relax muscles during surgery.
"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, PhD, senior vice president and head of neuroscience and ophthalmology for Merck Research Laboratories, in a press release. "Sugammadex sodium injection is an example of Merck's ongoing commitment to developing new medicines for patients in hospital-based settings."
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