Alembic Pharma gets USFDA nod for generic medication, Health News, ET HealthWorld

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Alembic Pharma gets USFDA nod for generic medication, Health News, ET HealthWorld

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New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures. The company has received approval from the US Food & ***** Administration (USFDA) for its Abbreviated New ***** Application (ANDA) Lamotrigine extended-release tablets (USP 200 mg, 250 mg, and 300 mg), the ***** firm said in a regulatory filing.

The approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC’s Lamictal XR extended-release tablets in strength of 200 mg, 250 mg, and 300 mg, it added.

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.

The ***** 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 *****.

According to IQVIA, Lamotrigine Extended-Release Tablets (200 mg, 250 mg, and 300 mg) have an estimated market size of USD 163 million for twelve months ending June 2024.

The company said it now has a cumulative total of 216 ANDA approvals from the USFDA.

• Published On Oct 3, 2024 at 01:54 PM IST

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