HAWTHORNE, N.Y., June 1, 2004 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq: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 lotion, 12%.
Taro's ammonium lactate lotion is bioequivalent to Bristol-Myers Squibb's Lac-Hydrin(R) lotion. Ammonium lactate lotion 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. U.S. sales of ammonium lactate lotion products were approximately $26.9 million in 2003, according to industry sources.
Taro's Second Ammonium Lactate, 12% Product
"Taro will now be able to provide both the cream and lotion forms of ammonium lactate," said Barrie Levitt, M.D., Chairman of the Company. "This approval continues to expand the range of therapeutic options that Taro provides to dermatologists." Taro received FDA approval for its ANDA for ammonium lactate, 12% cream in 2003.
Currently, Taro has 32 filings at the FDA: 31 ANDAs, including tentative approvals for fluconazole tablets and loratadine syrup, plus a New Drug Application related to the Company's proprietary NonSpil(TM) liquid drug delivery system. In addition, the Company has regulatory filings in Canada, Israel and other countries.
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, including statements regarding the Company's ammonium lactate products. 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; physician, pharmacist or patient acceptance of Taro's ammonium lactate products and other dermatology products; 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 2002 Annual Report on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.