Merck's new drug application resubmission for sugammadex sodium injection has been accepted for review by the FDA.
Neuromuscular blockade, which is used by anesthesiologists to relax muscles during surgery, is revered by the sugammadex sodium injection. Upon approval, this substance would be one of the first medicines of its kind to be used in the U.S. surgical setting.
The FDA previously rejected the NDA in 2008 and requested more data on allergic reactions and bleeding events. The application has now been deemed complete for review.
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Neuromuscular blockade, which is used by anesthesiologists to relax muscles during surgery, is revered by the sugammadex sodium injection. Upon approval, this substance would be one of the first medicines of its kind to be used in the U.S. surgical setting.
The FDA previously rejected the NDA in 2008 and requested more data on allergic reactions and bleeding events. The application has now been deemed complete for review.
More Articles on Anesthesia:
CMS Updates Locale Specific Anesthesia Conversion Rate
Novitas Expected to Revise Anesthesia Coverage Limits
Providence Washington Anesthesia Services Announces CME Symposium, Proceeds to Benefit Non-Profit