Business Editors/Health/Medical Writers
HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 10, 2003
Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS: TARO) reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for ammonium lactate cream, 12%.
Taro's ammonium lactate cream is bioequivalent to Bristol-Myers Squibb's Lac-Hydrin(R) cream. Ammonium lactate cream is a prescription product used for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. According to industry sources, 2002 U.S. sales of ammonium lactate cream products were approximately $34.5 million.
"Ammonium lactate cream gives physicians and patients an affordable option in treating skin disorders such as xerosis and ichthyosis vulgaris," said Barrie Levitt, M.D., Chairman of the Company. "This new product further enhances Taro's position as a leading supplier of topical dermatological products."
Currently, Taro has 23 filings at the FDA: 21 ANDAs, including one tentative approval, one unique supplemental ANDA, and a New Drug Application related to the Company's NonSpil(TM) liquid drug delivery system. 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 are 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. Such forward- looking statements may include, but are not limited to, statements regarding production and marketing of Taro's ammonium lactate cream, 12%. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, marketplace acceptance of Taro's ammonium lactate cream, 12%, the future size of the market for this product, 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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