HAWTHORNE, N.Y., Feb. 11, 2009 (GLOBE NEWSWIRE) -- Taro Pharmaceutical Industries Ltd. ("Taro," the "Company") (Pink Sheets:TAROF) reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Levetiracetam Oral Solution, 100 mg/mL ("levetiracetam oral solution").
Taro's levetiracetam oral solution is a prescription medication used as an adjunctive therapy in the treatment of partial onset seizures in individuals with epilepsy. This new Taro product is bioequivalent to UCB's Keppra(r) Oral Solution, 100 mg/mL. According to industry sources, Keppra(r) Oral Solution, 100 mg/mL had U.S. sales of approximately $90 million in 2008.
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 levetiracetam oral solution. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such 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 levetiracetam oral solution 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.