Mumbai, Feb. 26 -- The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets of GlaxoSmithKline LLC.

Lamotrigine is indicated as adjunctive therapy for patients aged two years and above for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures of Lennox-Gastaut syndrome. It is also indicated for conversion to monotherapy in certain adult patients with partial-onset seizures and for maintenance treatment of bipolar I disorder.

According to IQVIA data, the product has an estimated market size of US$ 27 million for the 12 months ended December 2025.

With this approval, Alembic now has a cumulative total of 235 ANDA approvals f...