Aurobindo Pharma has received the final approval from the US Food and Drug Administration (FDA) to manufacture and market Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, which are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Fycompa Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, of Catalyst Pharmaceuticals, Inc.

The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the company, and will be launched in Q3FY27.

The approved product has an estimated market size of USD 67 million for the 12 months ending August 2026, according to IQVIA MAT.

Aurobindo Pharma now has a total of 599 ANDA approvals (574 final approvals and 25 tentative approvals) from the FDA.

Perampanel Tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy 4 years of age and older, and is indicated as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in patients with epilepsy 12 years of age and older.