Alembic Pharma gets USFDA nod for anti-seizure drug but stock sees volatile moves

Alembic Pharmaceuticals Ltd. on Thursday, February 26, announced that it has received final approval from the US health regulator, the US Food and Drug Administration (USFDA), for its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets USP in strengths of 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, in the same strengths, marketed by GlaxoSmithKline LLC.

Lamotrigine is primarily used to treat seizures. According to IQVIA data, the estimated market size for the product is $27 million for the twelve months ending December 2025.
The drug is indicated as adjunctive therapy in patients aged two years and older for partial-onset seizures, primary generalised tonic-clonic (PGTC) seizures, and generalised seizures associated with Lennox-Gastaut syndrome.It is also indicated for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures who are currently being treated with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug (AED).

In addition, Lamotrigine is approved for the maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes in patients who have been treated for acute mood episodes with standard therapy.

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

Shares of Alembic Pharmaceuticals were trading lower at ₹738.20. The stock has declined 12% so far in 2026.