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A Tale Of Two Drugs: Atrial Fibrillation Reviews Draw Focus On RiskMAPS

Executive Summary

At the recent Cardiovascular and Renal Drugs Advisory Committee hearing for two atrial fibrillation drugs, the panel recommended approval of Astellas/Cardiome's Kynapid (vernakalant) without fully knowing its quantified risks, but shot down Solvay's Pulzium (tedisamil), which came with an extensive risk management plan and safety and efficacy data the committee touted as transparent and thorough

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