NDA 218158, held by Harrow Eye. Clobetasol Propionate.
As of Nov 13, 2026, NDA 218158 (Byqlovi), held by Harrow Eye, was first approved by FDA on Mar 4, 2024, with 1 approved supplement and 0 published complete response letters.
BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post- operative inflammation and pain following ocular surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Byqlovi0.05% · suspension/drops;ophthalmic | Clobetasol Propionate | RxReference drug |
| Apr 7, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Mar 4, 2024 | 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
