Alembic Pharmaceuticals

By Gurjot Singh , 28 February 2026

Indian drugmaker Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration to market Lamotrigine orally disintegrating tablets in the United States. The authorization covers multiple strengths under the abbreviated new drug application pathway, confirming therapeutic equivalence to the reference listed drug, Lamictal, marketed by GlaxoSmithKline LLC.