Teva Announces Tentative Approval of Buspirone HCL Tablets, 15mg

Business Wire, August 8, 2001

Business & Health Editors

JERUSALEM--(BUSINESS WIRE)--Aug. 8, 2001

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded tentative approval for Buspirone HCL Tablets, 15 mg.

With this approval, Teva has tentative approvals for the 3 strengths of Buspirone HCL tablets: 5, 10 and 15 mg.

Buspirone HCL Tablets is the generic version of Bristol Myers Squibb's Buspar(R) for the treatment of anxiety and anxiety with depression. Annual sales of the 15 mg brand in the U.S. are estimated to be $395 million.

Currently other competitors have the rights to an exclusive marketing period, which will end at the end of September 2001, after which multiple competitors may enter the market.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The Company develops, manufactures and markets generic and innovative 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 beliefs and expectations of management. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks and uncertainties that could cause the Company'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 the impact of pharmaceutical industry regulation, the difficulty of predicting 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, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on a strategy of acquiring companies and on strategic alliances, exposure to product liability claims, dependence on patent and other protections for our innovative products, fluctuations in currency, exchange and interest rates, operating results, and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S. Securities and Exchange Commission. 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.