Schering Plough’s Bridion Faces FDA Setback
This article was originally published in The Pink Sheet Daily
Safety concerns render anesthesia injection “not approvable” in U.S.
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Adequacy of data on risks of hypersensitivity/anaphylaxis and cardiac dysrhythmia with neuromuscular blockade reversal agent are focus of FDA advisory committee review.
After failing to submit safety data on time during the drug’s first FDA review, Merck has its data together and is armed with a new hypersensitivity study in advance of the second panel review for its anesthesia product.
Company expects to initiate the trial for the novel anesthesia injection this year.