Astellas/Cardiome’s Kynapid “Approvable”
This article was originally published in The Pink Sheet Daily
Executive SummaryFDA wants more safety data on IV vernakalant.
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Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.