Alembic Pharma Shares Jump on USFDA Approval for Lamotrigine Tablets

4 Oct 2024 , 10:39 AM

Alembic Pharmaceuticals’ shares increased by nearly 5% following the receipt of final approval from the US Food and Drug Administration (USFDA) for Lamotrigine Extended-Release tablets, used for managing certain seizure types.

At the time of writing on October 4, 2024 at 10:39 am, shares of Alembic Pharmaceuticals is currently trading at ₹1255.30 which is a 1.14% gain than the previous close.

This approval enhances Alembic Pharma’s portfolio, which now totals 216 Abbreviated New Drug Applications (ANDAs) from the USFDA, including 188 final and 28 tentative approvals. The approved Lamotrigine Extended-Release tablets are therapeutic equivalents of GlaxoSmithKline’s Lamictal XR, with strengths of 200 mg, 250 mg, and 300 mg.

These tablets are indicated as adjunctive therapy for patients aged 13 and older with primary generalized tonic-clonic seizures and partial-onset seizures, with or without secondary generalization.

Additionally, the drug is approved for monotherapy conversion for patients currently using a single antiepileptic drug for partial-onset seizures.

Market research by IQVIA estimates the market size for Lamotrigine Extended-Release tablets to be approximately $163 million for the 12 months ending June 2024.

Alembic Pharma, headquartered in India, is a prominent player in the global pharmaceutical sector, operating research and manufacturing facilities compliant with major regulatory standards, including the USFDA. The company plans to aggressively expand its US operations, aiming to launch over 20 products during the financial year 2025, after securing 11 new approvals since a slow start in the first quarter.