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Astellas/Cardiome's Vernakalant Wins Advisory Committee Approval In 6-2 Vote

This article was originally published in PharmAsia News

Executive Summary

FDA's Cardiovascular and Renal Drugs Advisory Committee voted to approve Astellas Pharma/Cardiome's new drug application for its antiarrhythmic Kynapid (vernakalant hydrochloride injection) Dec. 11

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Cardiome's Oct. 9 investor update, announcing a Nov. 14 meeting with U.S. regulators on its/Astellas' Kynapid NDA, adds little clarity on how long the drug's approval process could be delayed

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