Flarex

Treats steroid responsive inflammatory conditions of the palpebral and bulbar…. NDA 19079, held by Harrow Eye. Fluorometholone Acetate.

As of Nov 13, 2026, NDA 19079 (Flarex), held by Harrow Eye, was first approved by FDA on Feb 11, 1986, with 27 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1986
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Feb 11, 1986	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Flarex0.1% · suspension/drops;ophthalmic	Fluorometholone Acetate	RxReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 23, 2025	Supplement 41Labeling · Standard review	Approved	Letter Label
May 24, 2024	Supplement 38Labeling · Standard review	Approved	Letter
Aug 2, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 24, 2016	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 8, 2006	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 11, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 4, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 10, 2002	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 5, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 4, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 4, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 30, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 21, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 26, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Jul 19, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 13, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 4, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 9, 1986	Supplement 2Labeling	Approved	None posted
Mar 24, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 11, 1986	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19079
Drugs@FDA: Overview at FDA
Company: Harrow Eye LLC

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