FDA Panel Backs IV Cordarone Approval

31 October 1994

The US Food and Drug Administration's Cardiovascular & Renal Drugs Advisory Committee has given a positive recommendation for Wyeth-Ayerst Laboratories' Cordarone IV (amiodarone) as a treatment for life-threatening arrhythmias in patients who do not respond to lidocaine, procainamide or bretylium. The oral form of the drug was approved for this indication in 1985.

The panel voted five-two to approve the drug for marketing in the USA, after hearing a presentation on data from three pivotal studies of the drug in 917 patients, who were unresponsive to other therapies, within 72 hours of the onset of recurring ventricular fibrillation or hemodynamically destabilizing tachycardia.

The first study (protocol 300) involved 273 patients who received either 500mg, 1,000mg or 2,000mg of intravenous amiodarone. Protocol 309 was a revised dose study of 342 patients randomized to receive either 125mg, 500mg or 1,000mg amiodarone, and protocol 301 was a study comparing the effects of 125mg amiodarone, 1,000mg amiodarone and bretylium in 302 patients. Overall, iv amiodarone therapy was effective, with 86% of patients alive after 48 hours.

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