Schering-Plough’s Bridion Makes Positive Impression On Advisory Panel
This article was originally published in The Pink Sheet Daily
Advisory committee agrees sugammadex data on routine reversal of neuromuscular blockade is clinically relevant.
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Advisory committee suggests post-marketing epidemiological studies in higher risk patients to further assess risks of hypersensitivity, anaphylaxis and cardiac rhythm disorders with the neuromuscular blockade reversal agent.
Adequacy of data on risks of hypersensitivity/anaphylaxis and cardiac dysrhythmia with neuromuscular blockade reversal agent are focus of FDA advisory committee review.
FDA is conducting additional inspections of the site of a hypersensitivity study the agency requested in 2008; concerns about the study derailed a committee review in 2013.