New Delhi, February 26 Alembic Pharmaceuticals announced on Thursday that it has received approval from the US health regulator to market a generic medication for seizures.
The drug company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) of Lamotrigine oral disintegrating tablets in multiple strengths.
The company's approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC's reference listed drug product, Lamictal oral disintegrating tablets, Alembic Pharmaceuticals said in a statement.
Lamotrigine is indicated as adjunctive therapy in patients aged two years and older for partial-onset seizures, primary generalized tonic-clonic seizures, and generalized 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 anti-epileptic drug (AED).
According to IQVIA, Lamotrigine Oral 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 per share on BSE.
