Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Orally Disintegrating tablets

Alembic Pharmaceuticals 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, 25 mg, 50 mg, 100 mg and 200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of GlaxoSmithKline LLC.

Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, primary generalised tonic-clonic (PGTC) seizures and generalised 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 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.

Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg, have an estimated market size of US$ 27 million for the twelve months ending December 2025, according to IQVIA.

Alembic now has a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.