Alembic gains USFDA final approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product, Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GSK
Alembic Pharmaceuticals announced that it has received final approval from the USFDA for its 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 generalised tonic-clonic seizures and partial-onset seizures with or without secondary generalisation 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. Refer label for a detailed indication.
Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of $ 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.
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