The FDA has approved Actavis‘ ANDA for Lamotrigine Orally-Disintegrating Tablets, a generic equivalent to GlaxoSmithKline’s Lamictal ODT.
Lamictal ODT is an antiepileptic drug used as an adjunct in partial seizures, Lennox-Gastaut syndrome, or primary generalized tonic clonic seizures in adults and children. It is also indicated for the treatment of bipolar disorder.
Lamotrigine Orally-Disintegrating Tablets will be available in 25mg, 50mg, 100mg, and 200mg strengths. Actavis intends to launch the product immediately.
For more information visit Actavis.us.