Wyeth announced that the United States Food and Drug Administration (FDA) has denied Wyeth's antiarrhythmic drug Cordarone I.V. (amiodarone hydrochloride) six months of market exclusivity under the pediatric exclusivity provisions of the FDA Modernization Act of 1997 (FDAMA). FDA took this action because it concluded there was insufficient documentation to meet the provisions of the agency's written request. If the application had been approved, exclusivity would have been extended through February 3, 2003.

"The Company is disappointed with the FDA's decision. Wyeth conducted the first-ever study of Cordarone I.V. in a pediatric population. This study was very challenging because it was conducted in an intensive care setting. We believe it provides significant new information that can help guide doctors in using this important drug in critically ill children," says Bruce Burlington, Executive Vice President, Quality, Regulatory, and Safety for Wyeth Pharmaceuticals.

Cordarone I.V. was approved by the FDA in August 1995 under orphan drug status for the treatment and prevention of frequently recurring ventricular fibrillation and unstable ventricular tachycardia in patients refractory to other therapy. Today it has emerged as the most widely studied antiarrhythmic agent among those included in the ACLS (Advanced Cardiac Life Support) guidelines and is the only ACLS antiarrhythmic drug to be studied in randomized, placebo-controlled trials.

Cordarone I.V. is contraindicated in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block in the absence of a functioning pacemaker.

Hypotension is the most common adverse effect seen with Cordarone I.V. and may be related to the rate of infusion.