Wyeth-Ayerst Cordarone I.V. approved Aug. 3 for life-threatening arrhythmias in refractory patients.
Executive Summary
WYETH-AYERST CORDARONE INJECTION APPROVED AUG. 3 following two "approvable" phases. Cordarone (amiodarone) is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. A controlled study of the class III antiarrhythmic drug showed that a rapid onset regimen of Cordarone I.V. followed by maintenance infusion reduced episodes of VT "by 85% compared to baseline," labeling states.