For refractory complex partial seizures. ANDA 210155, held by Amneal Pharms. Vigabatrin.
As of Nov 15, 2026, ANDA 210155 (Vigabatrin), held by Amneal Pharms, was first approved by FDA on Mar 13, 2018, with 10 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 |
|---|---|---|---|
| Mar 13, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigabatrin500MG/PACKET · for solution;oral | Vigabatrin | Rx |
| Mar 18, 2026 | Supplement 21REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 19REMS | Approved | None posted |
| Nov 8, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 8, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 8, 2022 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 12, 2022 | Supplement 14REMS | Approved | None posted |
| Oct 2, 2020 | Supplement 10REMS | Approved | None posted |
| Apr 17, 2020 | Supplement 8REMS | Approved | None posted |
| Sep 12, 2019 | Supplement 4REMS | Approved | None posted |
| May 30, 2019 | Supplement 2REMS | Approved | None posted |
| Mar 13, 2018 | 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
