Reduces intraocular pressure (IOP). NDA 211911, held by Abbvie. Bimatoprost.
As of Nov 15, 2026, NDA 211911 (Durysta), held by Abbvie, was first approved by FDA on Mar 4, 2020, with 2 approved supplements and 0 published complete response letters.
DURYSTA (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Durysta10MCG · implant;ophthalmic | Bimatoprost | RxReference drug |
| Oct 10, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Nov 3, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Mar 4, 2020 | Original applicationNew dosage form · 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
