For refractory complex partial seizures. ANDA 210196, held by Bora. Vigabatrin.
As of Nov 15, 2026, ANDA 210196 (Vigadrone), held by Bora, was first approved by FDA on Jun 21, 2018, with 11 approved supplements and 0 published complete response letters.
VIGADRONE 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; VIGADRONE 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 |
|---|---|---|---|
| Jun 21, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigadrone500MG/PACKET · for solution;oral | Vigabatrin | Rx |
| Mar 18, 2026 | Supplement 22REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 20REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 14REMS | Approved | None posted |
| Aug 8, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 8, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 8, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 8, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 2, 2020 | Supplement 7REMS | Approved | None posted |
| Apr 17, 2020 | Supplement 5REMS | Approved | None posted |
| Sep 12, 2019 | Supplement 3REMS | Approved | None posted |
| May 30, 2019 | Supplement 1REMS | Approved | None posted |
| Jun 21, 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
