Treats partial-onset seizures with or without secondarily generalized seizures. ANDA 209538, held by Taro. Perampanel.
As of Nov 14, 2026, ANDA 209538 (Perampanel), held by Taro, was first approved by FDA on Nov 25, 2025, with 0 approved supplements and 0 published complete response letters.
Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2025 | Original application | Approved | None posted |
| Perampanel2MG · tablet;oral | Perampanel | Rx |
| Perampanel4MG · tablet;oral | Perampanel | Rx |
| Perampanel6MG · tablet;oral | Perampanel | Rx |
| Perampanel8MG · tablet;oral | Perampanel | Rx |
| Perampanel10MG · tablet;oral | Perampanel | Rx |
| Perampanel12MG · tablet;oral | Perampanel | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
