Alembic Pharma Gets USFDA Nod for Generic Drug

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures.

The drug firm has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lamotrigine orally disintegrating tablets in multiple strengths.

The company's approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC's reference listed drug product, Lamictal orally disintegrating tablets, Alembic Pharmaceuticals said in a statement.

Lamotrigine is indicated as adjunctive therapy in patients aged two years and older for the partial-onset seizures, primary generalised tonic-clonic seizures and generalised seizures of Lennox-Gastaut syndrome, it added.

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).

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

Alembic shares were trading 1.25 per cent down at Rs 729.20 apiece on BSE.