Apr 3, 2008 - Taro Pharmaceutical Industries Ltd. reported today that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg.
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal(R) Tablets. According to industry sources, Lamictal(R) 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.
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