Eurand received approval from the FDA for EUR-1048, to be marketed as GlaxoSmithKline’s Lamictal ODT (lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand and GSK, Lamictal ODT uses Eurand’s AdvaTab orally disintegrating tablet and Microcaps taste-masking technologies.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older, and is also used together with other medicines to treat certain types of seizures in people 2 years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in early July 2009.

Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing, royalties on sales, and milestone payments based on Lamictal ODT achieving predetermined sales in the U.S.