Treats diabetic macular edema (DME). NDA 201923, held by Alimera Sciences Inc. Fluocinolone Acetonide.
As of Nov 13, 2026, NDA 201923 (Iluvien), held by Alimera Sciences Inc, was first approved by FDA on Sep 26, 2014, with 3 approved supplements and 0 published complete response letters.
ILUVIEN is a corticosteroid indicated for: the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. 1.1 Diabetic Macular Edema ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2014 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Iluvien0.19MG · implant;intravitreal | Fluocinolone Acetonide | RxReference drug |
| Mar 12, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Mar 8, 2017 | Supplement 2Labeling · Standard review | Approved | |
| May 18, 2015 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 26, 2014 | Original applicationNew dosage form · Priority 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
