Caraco Wins Tentative OK for Generic Lamictal

November 20, 2007

After receiving tentative approval this week, Caraco Pharmaceutical Laboratories will likely begin marketing generic Lamictal tablets in January 2009 when the drug’s patent protection expires.

GlaxoSmithKline’s (GSK) blockbuster drug Lamictal (lamotrigine) is indicated in the treatment of partial seizures and for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes. Lamictal tablets had U.S. sales of approximately $1.89 billion during the 12-month period that ended in September, Caraco said, citing IMS Health data.

U.S. sales of Lamictal grew by 20 percent this past quarter, GSK said. The company received an approvable letter from the FDA in September for its application for Lamictal XR, a once-daily, extended-release formulation of the drug. GSK said it is discussing the next steps with the FDA.