Generic Equivalent to Sanofi-Aventis' Klaron(r) Lotion, 10%
HAWTHORNE, N.Y., May 21, 2009 (GLOBE NEWSWIRE) -- Taro Pharmaceutical Industries Ltd. ("Taro," the "Company,") (Pink Sheets:TAROF) reported today that its Canadian manufacturing site has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Sulfacetamide Sodium Topical Suspension USP, 10% (lotion) ("sulfacetamide sodium lotion").
Sulfacetamide sodium lotion is a prescription product used for the topical treatment of acne and is bioequivalent to the reference listed drug, Sanofi-Aventis' Klaron(r) Lotion, 10%. According to industry sources, branded and generic prescription sulfacetamide sodium lotion products (10%) had U.S. sales of approximately $15 million in the 12 months ending March 31, 2009.
Taro Pharmaceutical Industries Ltd. 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.
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Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's sulfacetamide sodium lotion product. 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 the new Taro sulfacetamide sodium lotion product and other 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 Annual Reports 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.
CONTACT: Kekst and Company