Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline’s Lamictal tablets.
The tentative ANDA approval for Taro’s Lamotrigine tablets is an FDA determination that Taro’s ANDA submission for this product satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions or any new information that may come to the FDA’s attention.