Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its Lamotrigine Orally Disintegrating Tablets USP in strengths of 25 mg, 50 mg, 100 mg and 200 mg.
The approval relates to Alembic’s abbreviated new drug application (ANDA) for a product therapeutically equivalent to Lamictal ODT, originally marketed by GlaxoSmithKline. Lamotrigine is indicated as adjunctive therapy for patients aged two years and older with partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures associated with Lennox-Gastaut syndrome.
It is also approved for conversion to monotherapy in certain adult patients currently receiving other antiepileptic drugs.
According to IQVIA data, the reference product recorded an estimated U.S. market size of approximately USD 27 million for the 12 months ending December 2025.
The approval further strengthens Alembic’s U.S. generics portfolio, adding to its growing list of ANDA clearances in the American market.
