Alembic Pharmaceuticals Ltd. Achieves US FDA Approval for Lamotrigine Tablets

Alembic Pharmaceuticals Ltd. announced on Thursday that it has received final approval from the US Food and Drug Administration for its tablets to treat primary generalised tonic-clonic seizures and partial-onset seizures.

The company has received approval for its abbreviated new drug application (ANDA) Lamotrigine extended-release tablets USP, 200 mg, 250 mg, and 300 mg, as per an exchange filing.

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 GlaxoSmithKline LLC.

The approved 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.

It is 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 have an estimated market size of $163 million, as per data 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 the US FDA.

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Shares of Alembic Pharmaceuticals were trading 3.41% higher at Rs 1,232.60 apiece, compared to a 2.02% decline in the benchmark NSE Nifty 50 at 2:02 p.m. The stock has risen 55.79% in the last 12 months and 62.22% year-to-date.

The total traded volume so far in the day stood at 0.65 times its 30-day average. The relative strength index was at 54.64.

Six out of the 17 analysts tracking the company have a 'buy' rating on the stock, eight recommend a 'hold' and three suggest a 'sell', according to Bloomberg data. The average of 12-month analyst price targets implies a potential downside of 11.2%.