Alembic Pharmaceuticals Gains USFDA Approval for Lamotrigine Tablets

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

The approved ANDA is for tablets that are therapeutically equivalent to the reference listed drug product, Lamictal ODT Orally Disintegrating Tablets, produced by GlaxoSmithKline LLC. Lamotrigine is indicated as adjunctive therapy for patients aged 2 years and older with partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut 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 specific antiepileptic drugs. Additionally, Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes.

The estimated market size for Lamotrigine Orally Disintegrating Tablets is USD 27 million for the twelve months ending December 2025, according to IQVIA data. This approval contributes to Alembic’s cumulative total of 235 ANDA approvals from the USFDA, which includes 216 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products globally. The company’s research and manufacturing facilities are approved by regulatory authorities in many developed countries, including the USFDA. Alembic is recognized as a leader in branded generics in India.