Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline (GSK). Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.

Also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug.

Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of US $163 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA.