USDA Approval of Alembic Pharma's Generic Formulation for Seizures
USDA Approval for Alembic Pharma's Generic Formulation
Alembic Pharmaceuticals Limited announced on Thursday that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, available in dosages of 200 mg, 250 mg, and 300 mg. This approval is significant as the generic formulation is therapeutically equivalent to the reference listed drug product Lamictal XR Extended-Release Tablets, manufactured by GlaxoSmithKline LLC (GSK).
Indications for Use
- Adjunctive therapy for primary generalized tonic-clonic seizures.
- Adjunctive therapy for partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
- Conversion to monotherapy for patients aged 13 years and older with partial-onset seizures.
The market for Lamotrigine Extended-Release Tablets has an estimated size of US$ 163 million for the twelve months ending June 2024, according to IQVIA data. This approval contributes to Alembic's impressive track record, with a cumulative total of 216 ANDA approvals from the USFDA.
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