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Astellas/Cardiome’s Kynapid “Approvable”

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA is seeking additional safety information on Astellas/Cardiome's Kynapid (vernakalant) injection for the treatment of atrial fibrillation. The companies announced receipt of an FDA "approvable" letter for the NDA Aug. 11

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