View printer-friendly version
« Back
April 26, 2000 3:23 p.m.
Teva Pharmaceutical Receives First FDA Approval of Ketoconazole 2% Cream

Jerusalem, Israel, April 26, 2000 - Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) today announced that it had received from the US Food and Drug Administration an approval to manufacture and market Ketoconazole 2% Cream. Teva USA will launch the product immediately.

Ketoconazole 2% Cream is Teva's generic version of Janssen's anti-fungal drug Nizoral® 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.







Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("FDA") and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.