Business Editors and Medical/Health Writers
JERUSALEM, Israel--(BUSINESS WIRE)--Sept. 5, 2002--Teva
Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the
U.S. Food and Drug Administration has approved the Company's ANDA for
Cefaclor Extended Release Tablets USP, 375 mg and 500 mg.
This is the first generic approval for the 375 mg strength.
Shipment of this product is expected to begin immediately.
Cefaclor Extended Release Tablets are the AB-rated generic
equivalent of Eli Lilly's Ceclor CD, marketed by Elan Corporation.
Cefaclor Extended Release Tablets are a cephalosporin antibiotic with
annual sales of $14 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 35 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 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
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