Alembic Pharmaceuticals Receives USFDA Final Approval for Lamotrigine Orally Disintegrating Tablets

Alembic Pharmaceuticals Limited has received US Food & Drug Administration (USFDA) Final Approval for Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline LLC. Lamotrigine is indicated for adjunctive therapy in patients aged 2 years and older 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 adults with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg, have an estimated market size of USS 27 million for twelve months ending December 2025 according to IQVIA.