Alembic Pharmaceuticals Limited (Alembic) announced on February 26, 2026, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, in strengths of 25 mg, 50 mg, 100 mg, and 200 mg.

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder.

Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for: i) partial-onset seizures, ii) primary generalized tonic-clonic (PGTC) seizures, and iii) generalized seizures of LennoxGastaut syndrome.

It is also indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. Refer label for a detailed indication.