Treats i nfantile spasms. NDA 217684, held by Pyros Pharms. Vigabatrin.
As of Nov 14, 2026, NDA 217684 (Vigafyde), held by Pyros Pharms, was first approved by FDA on Jun 17, 2024, with 4 approved supplements and 0 published complete response letters.
VIGAFYDE is indicated as monotherapy for the treatment of i nfantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. VIGAFYDE is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
| Sep 3, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jun 17, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigafyde100MG/ML · solution;oral | Vigabatrin | RxReference drug |
| Mar 18, 2026 | Supplement 7REMS | Approved | |
| Sep 3, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 3, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Sep 12, 2024 | Supplement 1REMS | Approved | |
| Jun 17, 2024 | Original applicationNew dosage form · Standard review | 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
