For refractory complex partial seizures. ANDA 215363, held by Msn. Vigabatrin.
As of Nov 15, 2026, ANDA 215363 (Vigabatrin), held by Msn, was first approved by FDA on Sep 7, 2022, with 3 approved supplements and 0 published complete response letters.
Vigabatrin for oral solution is 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 for oral solution is not indicated as a first line agent Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 7, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigabatrin500MG/PACKET · for solution;oral | Vigabatrin | Rx |
| Mar 18, 2026 | Supplement 6REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 2REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 1REMS | Approved | None posted |
| Sep 7, 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
