Teva Gets First Fda Approval Of Ketoconazole 2% Cream - Teva Pharmaceutical Industries Ltd - Brief Article - Statistical Data Included

Worldwide Biotech, June, 2000

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA), Jerusalem, has received from the US Food and Drug Administration an approval to manufacture and market Ketoconazole 2% Cream. Teva USA has launched the product.

Ketoconazole 2% Cream is Teva's generic version of Janssen's anti-fungal drug Nizoral(R) 2% Cream, of which annual US sales are approximately $65 million.

Teva views this approval as significant as it is the first approval for a generic version of this drug. Unlike most oral dosage forms, this product required a 325 patient, 18 center, double-blinded, three-way, placebo controlled clinical study to demonstrate bio-equivalence.

Teva Pharmaceutical Industries Limited is Israel's largest pharmaceutical company, with over 80% of its sales outside Israel mainly in the United States. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Corporate Headquarters are at 5 Basel St., P.O. Box 3190, Petah Tiqva 49131, Israel; Tel: 972-3-9267267, Fax: 972-3-9234050.

For more information, call (215)256-8400.