USDA Approves Alembic Pharma's Generic Seizure Treatment
Overview of Alembic Pharma's New Seizure Treatment
Alembic Pharmaceuticals Limited on Thursday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Extended-Release Tablets USP, available in 200 mg, 250 mg, and 300 mg dosages.
Details of the Approval
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets by GlaxoSmithKline LLC (GSK). These tablets are indicated for:
- Adjunctive therapy for primary generalized tonic-clonic seizures
- Partial-onset seizures with or without secondary generalization in patients aged 13 years and older
- Conversion to monotherapy in patients aged 13 years and older who are currently treating partial-onset seizures with a single antiepileptic drug
Market Insights
According to market insights from IQVIA, Lamotrigine Extended-Release Tablets USP have an estimated market size of US$ 163 million for the twelve months ending June 2024. Alembic has achieved a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from the USFDA.
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