Alembic Pharmaceuticals Receives USFDA Approval for Lamotrigine Orally Disintegrating Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Lamotrigine Orally Disintegrating Tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths. The drug, equivalent to GlaxoSmithKline's Lamictal ODT, is indicated for various seizure types and bipolar I disorder maintenance. The product's estimated US market size is $27 million for the year ending December 2025. This approval brings Alembic's total USFDA ANDA approvals to 235.