Reduces intraocular pressure (IOP). NDA 207795, held by Bausch And Lomb. Latanoprostene Bunod.
As of Nov 15, 2026, NDA 207795 (Vyzulta), held by Bausch And Lomb, was first approved by FDA on Nov 2, 2017, with 1 approved supplement and 0 published complete response letters.
VYZULTA (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyzulta0.024% · solution/drops;ophthalmic | Latanoprostene Bunod | RxReference drug |
| Jun 11, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Nov 2, 2017 | Original applicationNew molecular entity · 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
