GLAXOSMITHKLINE LLC

Alembic Pharma Gains US FDA Approval for Generic Lamotrigine Extended-Release Tablets

8 months ago

• Alembic Pharmaceuticals receives US FDA final approval for Lamotrigine Extended-Release Tablets USP (200 mg, 250 mg, and 300 mg). • The approved ANDA is therapeutically equivalent to GlaxoSmithKline's Lamictal XR, used to treat certain types of seizures. • Lamotrigine extended-release tablets are indicated for adjunctive therapy and monotherapy conversion in epilepsy patients 13 years and older. • The estimated market size for Lamotrigine Extended-Release Tablets is $163 million for the twelve months ending June 2024, according to IQVIA.