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27 Feb 2026
Admin
News Article

Alembic Pharma Wins USFDA Approval for Lamotrigine ODT

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for lamotrigine orally disintegrating tablets (ODT).

The approval covers four strengths: 25 mg, 50 mg, 100 mg, and 200 mg.

Therapeutic Equivalence to Lamictal ODT

Alembic’s lamotrigine ODT is therapeutically equivalent to the reference listed drug Lamictal ODT, marketed by GlaxoSmithKline LLC.

This equivalence allows Alembic to offer a generic alternative aligned with established clinical standards.

Indications: Seizure Disorders and Bipolar I Disorder

Lamotrigine is widely used across neurology and psychiatry.

Epilepsy indications

Approved as adjunctive therapy for patients aged 2 years and older for:

Partial-onset seizures
Primary generalized tonic-clonic (PGTC) seizures
Generalized seizures of Lennox–Gastaut syndrome

It is also approved for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures.

Bipolar disorder indication

Lamotrigine is indicated for the maintenance treatment of bipolar I disorder, helping delay the recurrence of mood episodes following acute treatment.

(Refer to the product label for full prescribing information.)

Strengthening Alembic’s US Generics Portfolio

With this approval, Alembic’s cumulative USFDA ANDA tally now stands at:

235 total ANDA approvals
- 216 final approvals
- 19 tentative approvals

The lamotrigine ODT approval further strengthens Alembic’s position in the US central nervous system (CNS) generics market.

About Alembic Pharmaceuticals

Founded in 1907, Alembic Pharmaceuticals is a vertically integrated, R&D-driven pharmaceutical company headquartered in India.

Publicly listed
Global manufacturing and marketing footprint
Strong focus on regulated markets, including the US

The Bigger Picture

USFDA approval for lamotrigine ODT adds another differentiated dosage form to Alembic’s portfolio. As demand for patient-friendly formulations grows, orally disintegrating tablets continue to play a key role in improving treatment adherence in chronic neurological conditions.

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