FDA grants tentative approval to Taro for Lamotrigine

HAWTHORNE, N.Y. Taro Pharmaceuticals has received tentative approval from the Food and Drug Administration for its application for Lamotrigine tablets.

Lamotrigine is the generic version of the GlaxoSmithKline epilepsy and bipolar I disorder drug Lamictal. It will be available in 25, 100, 150 and 200 mg strengths.

Lamictal had annual sales in the U.S. of about $2.6 billion.