For refractory complex partial seizures. ANDA 215707, held by Zydus Lifesciences. Vigabatrin.
As of Nov 15, 2026, ANDA 215707 (Vigabatrin), held by Zydus Lifesciences, was first approved by FDA on Jan 19, 2022, with 3 approved supplements and 0 published complete response letters.
Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 19, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigabatrin500MG · tablet;oral | Vigabatrin | Rx |
| Mar 18, 2026 | Supplement 6REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 3REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 1REMS | Approved | None posted |
| Jan 19, 2022 | Original application | 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
