For refractory complex partial seizures. ANDA 211539, held by Dr Reddys. Vigabatrin.
As of Nov 15, 2026, ANDA 211539 (Vigabatrin), held by Dr Reddys, was first approved by FDA on Jan 29, 2021, 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 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 |
|---|---|---|---|
| Jan 29, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigabatrin500MG · tablet;oral | Vigabatrin | Rx |
| Mar 18, 2026 | Supplement 3REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 2REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 1REMS | Approved | None posted |
| Jan 29, 2021 | 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
