Teva Announces Final Approval of Buspirone Tablets
February 28, 2002 1:46:00 PM ET
JERUSALEM, Israel--(BUSINESS WIRE)--Feb. 28, 2002--Teva Pharmaceutical Industries Ltd. TEVA announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg and 15 mg. Teva USA will launch the product immediately.
Buspirone Hydrochloride Tablets are the generic equivalent of Bristol-Myers Squibb's Buspar(R) Tablets for the treatment of anxiety.
Brand sales for the year before generic equivalent products became available in 2001 were approximately $611 million.
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 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 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 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.
Contact Information:
Teva Pharmaceutical Industries Ltd.
Dan Suesskind
Chief Financial Officer
(011) 972-2-589-2840
or
Teva North America
Bill Fletcher
President and CEO
(215) 591-8800
or
Teva Pharmaceutical Industries Ltd.
Dorit Meltzer |
