Alembic Pharma gets USFDA nod for Lamotrigine tablets

Alembic Pharmaceuticals announced 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, 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 of GlaxoSmithKline LLC.

Lamotrigine is indicated as adjunctive therapy for patients aged two years and above 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 certain adult patients with partial-onset seizures and for maintenance treatment of bipolar I disorder.

According to IQVIA data, the product has an estimated market size of US$ 27 million for the 12 months ended December 2025.

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

Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company?s consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.

The counter rose 0.39% to Rs 741.30 on the BSE.

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