Teva Announces Tentative Approval of Generic Maxalt(R) Tablets

Thu Apr 17, 2008 8:42am EDT

* Reuters is not responsible for the content in this press release.

JERUSALEM--(Business Wire)--
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today
that the U.S. Food and Drug Administration has granted tentative
approval for the Company's Abbreviated New Drug Application (ANDA) to
market its generic version of Merck's migraine pain treatment
Maxalt(R) (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg
base. Final approval of this product is anticipated upon expiration of
patent protection for the brand product in June 2012.

   The brand product had annual sales of approximately $193 million
in the United States for the twelve months that ended December 30,
2007, based on IMS sales data.

   About Teva

   Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
world's leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.

   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 management's current beliefs and 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 risks relating
to: when and whether the proposed acquisition will be consummated,
Teva's ability to rapidly integrate Bentley's operations with its own
operations and achieve expected synergies, the diversion of management
time on merger-related issues, Teva's ability to accurately predict
future market conditions, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic versions of Allegra(R),
Neurontin(R), Lotrel(R), Famvir(R) and Protonix(R), Teva's ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the
extent to which Teva may obtain U.S. market exclusivity for certain of
its new generic products and regulatory changes that may prevent Teva
from utilizing exclusivity periods, competition from brand-name
companies that are under increased pressure to counter generic
products, or competitors that seek to delay the introduction of
generic products, the impact of consolidation of our distributors and
customers, the effects of competition on our innovative products,
especially Copaxone(R) sales, 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, European Medicines Agency and other regulatory
authority approvals, the regulatory environment and changes in the
health policies and structures of various countries, our ability to
achieve expected results though our innovative R&D efforts, Teva's
ability to successfully identify, consummate and integrate
acquisitions, potential exposure to product liability claims to the
extent not covered by insurance, dependence on the effectiveness of
our patents and other protections for innovative products, significant
operations worldwide that may be adversely affected by terrorism,
political or economical instability or major hostilities, supply
interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain,
environmental risks, fluctuations in currency, exchange and interest
rates, 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. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.

Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
or
Teva North America
Kevin Mannix, 215-591-8912

Copyright Business Wire 2008
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