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