TEVA GETS FIRST FDA APPROVAL OF KETOCONAZOLE 2% CREAM.Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :TEVA), Jerusalem, has received from the US Food and Drug Administration an approval to manufacture and market Ketoconazole ketoconazole /ke·to·co·na·zole/ (ke?to-kon´ah-zol) a derivative of imidazole used as an antifungal agent. ke·to·co·na·zole n. 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 A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. , 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . 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. |
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