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| |  Cordarone I.V. Receives FDA Clearance PHILADELPHIA -- Aug. 8, 1995 -- Wyeth-Ayerst Laboratories has received market clearance for Cordarone(R) I.V. (amiodarone HCI), a new product for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT), in patients refractory to other therapy. Cordarone I.V. also can be used to treat patients with VF/VT for whom oral Cordarone(R) (amiodarone HCI) is indicated, but who are unable to take oral medication. Cordarone I.V. will have seven-year exclusivity by virtue of it being granted orphan drug status. Wyeth-Ayerst Laboratories is a division of American Home Products Corporation (NYSE:AHP). "Typically, patients who are candidates for treatment with Cordarone I.V. are seriously ill cardiac patients who are experiencing acute and recurrent episodes of life-threatening ventricular arrhythmias." said Marc Deitch, M.D., Vice President of Medical Affairs and Medical Director, Wyeth-Ayerst Laboratories. "They are likely to have underlying heart disease and an overall poor prognosis. There may be very few alternatives available to them, and that makes Cordarone I.V. a particularly important new product. We at Wyeth-Ayerst Laboratories are certain that the physicians who treat these patients will find Cordarone I.V. a welcome addition to the treatment protocol." In clinical trials, which involved only patients with the most severe, life-threatening arrhythmias and underlying cardiac diseases, 85% of the patients on Cordarone I.V. survived the critical first 24 hours, Without a placebo comparison, a mortality benefit could not be established. In these trials, the most common side effect, hypotension (16%), required discontinuation in only 1.6% of patients. Cordarone I.V. is contraindicated in patients with cardiogenic shock, marked sinus bradycardia, and/or second- and third-degree AV block in the absence of a functioning pacemaker. With its introduction in the U.S., Cordarone I.V. will now be available in more than 100 countries, The oral form of Cordarone has been on the market in the U.S. since 1985. Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, infant nutritionals and generic pharmaceuticals. American Home Products Corporation ranks among the world leaders in sales of pharmaceuticals and health-care products. It is also a leader in agricultural products, animal health care, medical devices and food products. CONTACT: Wyeth-Ayerst | Audrey Ashby, 610/971-5823 | or | Parallax Communications | Anne Rogers, 317/638-7898
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