Taro Receives Tentative FDA Approval For Lamotrigine Tablets ANDA

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Apr 2008 - 3:00 PDT


Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg ("Lamotrigine Tablets").

Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal® Tablets. According to industry sources, Lamictal® Tablets had annual U.S. sales of approximately $2.6 billion.

The tentative ANDA approval for Taro's Lamotrigine Tablets is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.

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 http://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 lamotrigine 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 failure to receive final approval for Taro's ANDA submission for Lamotrigine Tablets; the granting of additional exclusivities or restrictions to Lamictal® Tablets; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's Lamotrigine Tablets; 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.

Taro Pharmaceutical Industries Ltd.

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