Lamictal ODT, orally disintegrating tablets, approved

The FDA has approved Lamictal ODT (lamotrigine, from GlaxoSmithKline) orally disintegrating tablets. This approval was based on the demonstrated bioequivalence of Lamicatal ODT to Lamictal tablets. Lamictal ODT offers an option to patients with bipolar disorder or epilepsy who have difficulty swallowing tablets.

Lamictal ODT is indicated for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in patients ≥18years of age who have been treated for mood episodes with other medication. Lamictal ODT is also indicated in combination with other drugs to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in patients ≥2 years of age, or as monotherapy when changing from other drugs used to treat partial seizures in patients ≥16 years of age.

Lamictal ODT is expected to be available early July 2009 in 25mg, 50mg, 100mg, and 200mg dosage strengths.

For more information call (888) 825-5249 or visit www.lamictal.com.