Treats partial-onset seizures with or without secondarily generalized seizures. ANDA 209801, held by Teva Pharms USA Inc. Perampanel.
As of Nov 14, 2026, ANDA 209801 (Perampanel), held by Teva Pharms USA Inc, was first approved by FDA on May 23, 2025, with 0 approved supplements and 0 published complete response letters.
Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are 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 |
|---|---|---|---|
| May 23, 2025 | Original application | Approved |
| 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
