FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of April 2008
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Commission File Number 0-16174
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TEVA PHARMACEUTICAL INDUSTRIES LIMITED
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(Translation of registrant's name into English)
5 Basel Street, P.O. Box 3190
Petach Tikva 49131 Israel
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(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
Form 20-F X Form 40-F
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Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(1): ______________
Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(7): ______________
Indicate by check mark whether by furnishing the information contained in
this Form, the registrant is also hereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
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If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g(3)-2(b): 82-___________
[GRAPHIC OMITTED][GRAPHIC OMITTED] Website: www.tevapharm.com
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Contact: Elana Holzman Teva Pharmaceutical Industries Ltd. 972 (3) 926-7554
Kevin Mannix Teva North America (215) 591-8912
For Immediate Release
TEVA ANNOUNCES TENTATIVE APPROVAL OF GENERIC
EVISTA(R) TABLETS
Jerusalem, Israel, April 17, 2008 - 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 Lilly's osteoporosis treatment Evista(R)
(Raloxifene Hydrochloride) Tablets, 60 mg.
The brand product had annual sales of approximately $691 million in the United
States for the twelve months that ended December 31, 2007, based on IMS sales
data.
Teva is currently involved in patent litigation concerning this product in the
U.S. District Court for the Southern District of Indiana. A trial date has not
been set.
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
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of 1995:
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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(Registrant)
By: /c/ Dan Suesskind
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Name: Dan Suesskind
Title: Chief Financial Officer
Date: April 18, 2008