Treats partial-onset or primary generalized tonic-clonic seizures. NDA 214679, held by Azurity. Topiramate.
As of Nov 13, 2026, NDA 214679 (Eprontia), held by Azurity, was first approved by FDA on Nov 5, 2021, with 4 approved supplements and 0 published complete response letters.
EPRONTIA is indicated for: Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Preventive treatment of migraine in patients 12 years of age and older. 1.1 Monotherapy Epilepsy EPRONTIA is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2021 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eprontia25MG/ML · solution;oral | Topiramate | RxReference drug |
| Mar 6, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Mar 12, 2025 | Supplement 9Labeling · Standard review | Approved | |
| May 17, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Oct 26, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Nov 5, 2021 | Original applicationNew dosage form · Standard review | Approved |
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
