Alembic Pharmaceuticals Receives US FDA Final Approval For Lamotrigine Extended-Release Tablets USP

Alembic Pharmaceuticals Limited recently gained final approval from the U.S. Food and Drug Administration (US FDA), for its Abbreviated New Drug Application, ANDA, for Lamotrigine Extended-Release Tablets USP in 200 mg, 250 mg, and 300 mg. This approval means that Alembic's product is therapeutically equivalent to GlaxoSmithKline LLC's reference product, Lamictal XR Extended-Release Tablets, in the same dosages.

Lamotrigine Extended-Release Tablets are prescribed as an auxiliary therapy for primary generalised tonic-clonic seizures and partial-onset seizures, both with and without secondary generalization—in patients aged 13 years and older. They are also approved for transitioning to monotherapy for patients of the same age who are currently being treated with a single antiepileptic drug. 

According to IQVIA, The US market for Lamotrigine Extended-Release Tablets is estimated to be around $163 million for the twelve months ending June 2024. The Alembic's approval now made a cumulative total of 216 ANDA approvals, comprising 188 final approvals and 28 tentative approvals.