FDA Approves Teva's Sotalol Hydrochloride Tablets

Teva Pharmaceutical Industries Ltd. (Jerusalem) has received final U.S. Food and Drug Administration (FDA) approval to manufacture and market Sotalol Hydrochloride Tablets in various dosage forms. The product is a generic version of Schering AG's drug Betapace for treatment of documented vertricular arrhythmias.

FDA also granted the approval c to a number of other companies. Teva will launch the product immediately through its Teva USA subsidiary.

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company with over 80% of its sales outside Israel, mainly in the United States. The company specializing in developing, manufacturing, and marketing generic and branded human pharmaceuticals and active pharmaceutical ingredients.

For more information: Teva Pharmaceutical Industries Ltd., 5 Basel St., PO Box 3190, Petah Tikva 49131, Israel. Tel: +972-3-926-7267. Fax: +972-3-923-4050.

Edited by Jim Pomager