SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2002
Taro Pharmaceutical Industries Ltd.
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(Translation of registrant's name into English)
14 Hakitor Street, Haifa Bay 26110, Israel
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(Address of principal executive office)
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 |_|
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes |_| No |X|
The following is included in this Report on Form 6-K:
1. Press release dated November 26, 2002.
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TARO PHARMACEUTICAL INDUSTRIES LTD.
C/O TARO PHARMACEUTICALS U.S.A., INC.
Five Skyline Drive
Hawthorne, New York 10532
TAR0 NEWS (Nasdaq/NMS: TARO)
AT THE COMPANY
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Daniel Saks Kevin Connelly
Vice President, Corporate Affairs Chief Financial Officer
(914) 345-9000 ext. 208 (914) 345-9000 ext. 338
FOR IMMEDIATE RELEASE
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TUESDAY, NOVEMBER 26, 2002
TARO RECEIVES APPROVAL FOR ECONAZOLE NITRATE
CREAM 1% ANDA Generic Equivalent to Spectazole(R)Cream
HAWTHORNE, NY, NOVEMBER 26, 2002 - Taro Pharmaceutical Industries Ltd.
(Nasdaq/NMS: TARO) reported today that the Company has received approval from
the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug
Application ("ANDA") for Econazole Nitrate Cream 1% ("Econazole Cream").
Taro's Econazole Cream is bioequivalent to Ortho Dermatological's Spectazole(R)
Cream. This prescription pharmaceutical is used primarily in treating fungal
infections of the skin. Taro believes it has the first U.S. approval to
manufacture and market a generic equivalent to Spectazole(R).
According to industry sources, U.S. sales of Spectazole(R) Cream were
approximately $54 million in 2001. Taro is a leader in the U.S. markets for
topical corticosteroids and antifungal medications, including both prescription
and over-the-counter drugs.
"This approval again demonstrates Taro's ability to conduct the extensive
clinical studies required by the FDA for approval of topical antifungal
products," said Barrie Levitt, M.D., Chairman of the Company.
Taro currently has 17 ANDAs on file with the U.S. Food and Drug Administration,
including one tentative approval. In addition, the Company has multiple
regulatory filings in Canada, Israel and other countries around the world.
Taro is a multinational, science-based pharmaceutical company, dedicated to
meeting the needs of its customers through the discovery, development,
manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the
Company's website at www.taro.com.
Certain statements in this release may be forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Although Taro
Pharmaceutical Industries Ltd. believes the expectations reflected in such
forward-looking statements to be based on reasonable assumptions, it can give no
assurance that its expectations will be attained. Factors that could cause
actual results to differ include industry and market conditions, slower than
anticipated penetration of new markets, marketplace acceptance of generic
Econazole Cream, the future size of the market for Econazole Cream, changes in
the Company's financial position, regulatory actions, and other risks detailed
from time to time in the Company's SEC reports, including its 2001 Annual Report
on Form 20-F.
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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.
Taro Pharmaceutical Industries Ltd.
Date: December 2, 2002 By:/s/ Kevin Connelly
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Kevin Connelly
Senior Vice President and Chief
Financial Officer
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