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Cardiome Expects Anti-Arrhythmic NDA Submission By 2006

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cardiome plans NDA for lead anti-arrhythmic compound RSD1235 by 2006. In a Phase III study, 52% of patients with recent-onset atrial fibrillation converted to normal heart rhythm compared to 4% for placebo. RSD1235 could merit premium pricing to amiodarone (Wyeth’s Cordarone), Cardiome says
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