Reduces elevated intraocular pressure (IOP). NDA 204251, held by Alcon Labs Inc. Brimonidine Tartrate; Brinzolamide.
As of Nov 14, 2026, NDA 204251 (Simbrinza), held by Alcon Labs Inc, was first approved by FDA on Apr 19, 2013, with 5 approved supplements and 0 published complete response letters.
SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2013 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simbrinza0.2%;1% · suspension/drops;ophthalmic | Brimonidine Tartrate; Brinzolamide | RxReference drug |
| May 5, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Jun 9, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 20, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2015 | Supplement 6Labeling · Standard review | Approved | |
| Apr 19, 2013 | Original applicationNew combination · 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
