Astellas/Cardiome’s Kynapid “Approvable”
This article was originally published in The Pink Sheet Daily
FDA 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.
Merck & Co. is acquiring North American rights to intravenous vernakalant from Astellas Pharma's U.S. subsidiary, Merck announced on July 26. The agreement will consolidate its interest in the cardiovascular drug to include worldwide rights to both the IV and oral formulations
Already holding worldwide rights to the oral formulation and rest-of-world rights to intravenous vernakalant, Merck will partner with Cardiome Pharma to obtain FDA approval of IV vernakalant.