Treats dry eye disease. NDA 217469, held by Harrow Eye. Cyclosporine.
As of Nov 14, 2026, NDA 217469 (Vevye), held by Harrow Eye, was first approved by FDA on May 30, 2023, with 2 approved supplements and 0 published complete response letters.
VEVYE indicated for the treatment of the signs and symptoms of dry eye disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vevye0.1% · solution;ophthalmic | Cyclosporine | RxReference drug |
| Sep 18, 2025 | Supplement 7Labeling · Standard review | Approved | |
| May 28, 2024 | Supplement 3Labeling · Standard review | Approved | |
| May 30, 2023 | Original applicationNew formulation or manufacturer · 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
