Teva Receives First Generic Approval for Amoxicillin 500 and 875 mg Tablets

Business Wire, Sept 19, 2000

Business & Health Editors

JERUSALEM, Israel--(BUSINESS WIRE)--Sept. 19, 2000

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the U.S. FDA final approval to manufacture and market Amoxicillin 500 and 875 mg Tablets, intended for twice-daily dosage.

Amoxicillin is the generic version of SmithKline Beecham's Amoxil(R), for the treatment of infections due to susceptible organisms. Sales of these strengths of the branded product in the U.S. were approximately $34 million in 1999.

Teva's application was the first approval for a generic version of these strengths of Amoxil(R). Teva intends to launch the product imminently.

Teva Pharmaceutical Industries Ltd. headquartered in Israel is among the top 50 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are outside Israel, mainly in North America and Europe. The Company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Statement: This report contains forward-looking statements, which express the 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 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 strategic alliances, fluctuations in currency, exchange and interest rates, operating results, the impact of the year 2000 issue 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.