Alembic Pharmaceuticals Secures USFDA Nod for Seizure Drug

Alembic Pharmaceuticals announced on Thursday that it has secured approval from the US FDA to sell a generic version of a seizure medication. The green light from the US regulator pertains to Alembic's Lamotrigine orally disintegrating tablets, which have been approved in multiple strengths.

The newly approved product is therapeutically equivalent to GlaxoSmithKline’s Lamictal orally disintegrating tablets, the company stated. Lamotrigine serves as an adjunctive therapy for patients as young as two years old experiencing partial-onset seizures and various generalized seizures, including those from Lennox-Gastaut syndrome.

The tablets are also indicated for adults converting to monotherapy with partial-onset seizures. As of December 2025, the market for this medication variant is predicted to reach USD 27 million. Despite the approval, Alembic’s shares fell by 1.25%, trading at Rs 729.20 on the BSE.