Aurobindo Pharma has received the final approval for lamotrigine tablets (chewable, dispersible) 5 mg and 25 mg from the US Food and Drug Administration (US FDA).
Lamotrigine tablets 5 mg and 25 mg is generic equivalent to Lamictal CD tablets 5 mg and 25 mg of GlaxoSmithKline. Lamotrigine tablet falls under the CNS (Central Nervous System) segments and is indicated as adjunctive therapy for partial seizers and generalised seizures of Lennox-Gastaut syndrome in patients aged 2 years and older, and for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug. The product would be launched soon.
At present, the company has a total of 107 ANDA approvals (78 final approvals and 29 tentative approvals) from US FDA.