Treats postoperative inflammation and reduction of ocular pain. NDA 203168, held by Bausch And Lomb. Bromfenac Sodium.
As of Nov 13, 2026, NDA 203168 (Prolensa), held by Bausch And Lomb, was first approved by FDA on Apr 5, 2013, with 3 approved supplements and 0 published complete response letters.
Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ProlensaEQ 0.07% ACID · solution/drops;ophthalmic | Bromfenac Sodium | RxReference drug |
| Feb 18, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Dec 2, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 1, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 5, 2013 | 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
