India Drug Approvals — October 03, 2026
Aurobindo Pharma has secured USFDA final approval for Perampanel Tablets (2-12 mg), a generic equivalent of Fycompa® used for partial-onset seizures and primary generalized tonic-clonic seizures. The product will be manufactured at APL Healthcare and launched in Q3FY27, targeting a US market size of US$67 million (IQVIA MAT Aug 2026). This approval adds to Aurobindo's strong US generics portfolio, now totaling 599 ANDA approvals (574 final, 25 tentative). The development is positive for Aurobindo's revenue diversification and CNS franchise, though pricing dynamics and competition from other generic entrants remain key factors. With no period-over-period financial data or insider activity in this filing, the focus is on the approval's strategic value and near-term catalyst.