Reduces elevated intraocular pressure (IOP). NDA 21398, held by Abbvie. Brimonidine Tartrate; Timolol Maleate.
As of Nov 14, 2026, NDA 21398 (Combigan), held by Abbvie, was first approved by FDA on Oct 30, 2007, with 3 approved supplements and 0 published complete response letters.
COMBIGAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of COMBIGAN dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2007 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Combigan0.2%;EQ 0.5% BASE · solution/drops;ophthalmic | Brimonidine Tartrate; Timolol Maleate | RxReference drug |
| Mar 17, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Oct 15, 2015 | Supplement 7Labeling · Standard review | Approved | |
| Oct 11, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Oct 30, 2007 | 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
