New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic drug for seizures. The company has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for lamotrigine extended-release tablets (USP 200 mg, 250 mg and 300 mg), the drug firm said in a regulatory filing. .
The approved ANDA strengths of 200 mg, 250 mg and 300 mg are therapeutically equivalent to Lamictal XR extended-release tablets from GlaxoSmithKline LLC.
Lamotrigine extended-release tablets are indicated for the adjunctive therapy of primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients 13 years of age and older.
The drug is also indicated for conversion to monotherapy in patients 13 years of age and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug.
According to IQVIA, Lamotrigine extended-release tablets (200 mg, 250 mg, and 300 mg) have an estimated market size of USD 163 million for the twelve months ending June 2024.
The company said it now has a total of 216 ANDA approvals from the USFDA.
