Teva Announces Final Approval of Fluoxetine Oral Solution
180-Day Market Exclusivity
JERUSALEM, Israel, Aug 2, 2001 (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA chart, msgs) announced today that the U.S. Food and Drug Administration (FDA) has awarded final approval for fluoxetine oral solution.
Launch is anticipated to begin immediately.
Fluoxetine Oral Solution is the generic version of Dista's antidepressant, Prozac(R) Oral Solution, which had U.S. 2000 branded sales of approximately $30 million.
As the first applicant to challenge the listed patents for this drug formulation, Teva is entitled to a 180-day period of generic marketing exclusivity.
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 85% 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, 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.
Contact:
Teva Pharmaceutical Industries Ltd.
Dan Suesskind, (011) 972-2-589-2840
or
Investor Relations
Dorit Meltzer, (011) 972-3-926-7554
or
Teva North America
Bill Fletcher, 215/591-8800
www.tevapharm.com |
