Alembic Pharma Receives USFDA Approval for Generic Lamotrigine Extended-Release Tablets for Seizures
Alembic Pharma's FDA Approval for Lamotrigine Extended-Release Tablets
Alembic Pharmaceuticals has officially received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine extended-release tablets. This generic medication, available in dosages of 200 mg, 250 mg, and 300 mg, serves as a therapeutically equivalent alternative to GlaxoSmithKline LLC's Lamictal XR extended-release tablets.
Details on Indications and Market
- Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures.
- They also cater to partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
- Additionally, they are indicated for conversion to monotherapy in patients with partial-onset seizures.
Market Insights
According to IQVIA, the estimated market size for Lamotrigine extended-release tablets (200 mg, 250 mg, and 300 mg) is around USD 163 million for the twelve months ending June 2024. Alembic Pharma has now achieved a total of 216 ANDA approvals from the USFDA.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.