Aurobindo Pharma wins final USFDA approval

has received final USFDA approval for Perampanel Tablets in six strengths ranging from 2 mg to 12 mg. The product is bioequivalent to Fycompa Tablets and will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary. The company expects to launch the product in Q3 FY27, targeting an estimated US market of US$67 million based on IQVIA MAT data through August 2026. Perampanel is indicated for the treatment of partial-onset seizures in patients aged 4 years and above, and as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 12 years and above. This approval takes Aurobindo Pharma’s total USFDA ANDA approvals to 599, including 574 final and 25 tentative approvals. My View: The approval is positive for Aurobindo Pharma as it adds another CNS product to its US portfolio and provides a potential revenue opportunity from launch in Q3 FY27. What to watch: Track the Q3 FY27 launch, market uptake, pricing and competition in the US, along with further USFDA approvals and product launches. Stance: AUROPHARMA – POSITIVE