Ozurdex

NDA 22315, held by Abbvie. Dexamethasone.

As of Nov 14, 2026, NDA 22315 (Ozurdex), held by Abbvie, was first approved by FDA on Jun 17, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 17, 2009
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) The treatment of non-infectious uveitis affecting the posterior segment of the eye The treatment of diabetic macular edema 1.1 Retinal Vein Occlusion OZURDEX (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). 1.2 Posterior Segment Uveitis OZURDEX is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jun 28, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 24, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2009	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ozurdex0.7MG · implant;intravitreal	Dexamethasone	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Mar 11, 2026	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 19, 2022	Supplement 16Labeling · Standard review	Approved	Label Letter
Oct 21, 2020	Supplement 13Labeling · Standard review	Approved	Letter Label
May 15, 2018	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 5, 2016	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 26, 2014	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 28, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 7, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 7, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Feb 24, 2012	Supplement 5Labeling · Standard review	Approved	Letter Label
Sep 24, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 31, 2010	Supplement 2Labeling	Approved	Letter
Jun 17, 2009	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22315
Drugs@FDA: Overview at FDA
Company: AbbVie

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