Alembic Pharmaceuticals Secures USFDA Final Approval for Lamotrigine Orally Disintegrating Tablets
Lamotrigine is indicated as adjunctive therapy in patients aged two years and older for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures and generalized seizures associated with Lennox-Gastaut syndrome.
Epilepsy and bipolar disorder treatment has estimated US market size of $27 million
Mumbai: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets USP in strengths of 25 mg, 50 mg, 100 mg and 200 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug Lamictal ODT Orally Disintegrating Tablets of GlaxoSmithKline LLC.
Lamotrigine is indicated as adjunctive therapy in patients aged two years and older for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures and generalized seizures associated with Lennox-Gastaut syndrome. It is also approved for conversion to monotherapy in adults aged 16 years and above with partial-onset seizures who are being treated with specific antiepileptic drugs.
Additionally, Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes in patients who have been treated for acute mood episodes with standard therapy.
According to IQVIA data, Lamotrigine Orally Disintegrating Tablets in these strengths have an estimated US market size of $27 million for the twelve months ending December 2025.
With this approval, Alembic now has a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.
Alembic Pharmaceuticals, a vertically integrated research and development company established in 1907, manufactures and markets generic pharmaceutical products globally. The company operates state-of-the-art research and manufacturing facilities approved by regulatory authorities in several developed markets, including the USFDA, and is among the leaders in branded generics in India.
