HAWTHORNE, N.Y., Feb. 5, 2009 (GLOBE NEWSWIRE) -- Taro Pharmaceutical Industries Ltd. ("Taro," the "Company,") (Pink Sheets:TAROF) reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Lamotrigine Tablets (Chewable Dispersible), 5 mg and 25 mg ("lamotrigine chewable tablets").
Lamotrigine chewable tablets, marketed by GlaxoSmithKline as Lamictal(r) CD Tablets, is a prescription pharmaceutical product used in treating seizures. Taro previously filed a "Paragraph IV" certification challenging GlaxoSmithKline's patent protection on Lamictal(r). According to industry sources, lamotrigine chewable tablet products had annual U.S. sales of approximately $70 million.
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 lamotrigine chewable tablets. 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 lamotrigine chewable tablets 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.