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Alembic Pharmaceuticals Limited announces USFDA Final Approval for Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg

Posted On : 2026-02-26 16:38:26( TIMEZONE : IST )

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline LLC.

Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for: i) partial-onset seizures, ii) primary generalized tonic-clonic (PGTC) seizures, and iii) generalized seizures of LennoxGastaut syndrome. It is also indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. Refer label for a detailed indication.

Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg, have an estimated market size of US$ 27 million for twelve months ending December 2025 according to IQVIA.

Alembic has a cumulative total of 235 ANDA approvals (216 final approvals and 19 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 738.40 as compared to the previous close of Rs. 750.15. The total number of shares traded during the day was 2313 in over 330 trades.

The stock hit an intraday high of Rs. 771.75 and intraday low of 732.50. The net turnover during the day was Rs. 1724095.00.