Fluorometholone

Treats corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva…. Sold as Oxylone, Fml, Fml Forte. Every FDA application for this active ingredient: 4 branded and 3 generic.

As of Nov 15, 2026, FDA lists 7 applications for Fluorometholone (sold as Oxylone, Fml, Fml Forte), first approved Jan 12, 1972, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 12, 1972
Applications: 7
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $33.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fluorometholone	Part D	$31.6M	+2%	225,212
Fml Forte	Part D	$1.0M	+15%	2,710
Flarex	Part D	$1.0M	-62%	4,390
Fml	Part D	$64K	-43%	164

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLUOROMETHOLONE 0.1% EYE DROP: $11.03 per MLGeneric · -15% in a year
FML FORTE 0.25% EYE DROPS: $32.16 per MLBrand · 0% in a year

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled TrialGlaucoma, Trabeculectomy · Benha University	Not applicable	Recruiting	Aug 10, 2026
Vevye + Flarex Combination Therapy for Dry EyeDry Eye · Canyon City Eyecare	Phase 4	Enrolling by invitation	Apr 28, 2026
Fluorometholone StudyKeratitis Bacterial, Corneal Ulcer (Diagnosis) · Vishal Jhanji	Phase 2	Not yet recruiting	Dec 30, 2025
The OPTIMISE StudyPseudophakic Bullous Keratopathy, Fuchs' Endothelial Dystrophy · Maastricht University Medical Center	Phase 4	Recruiting	Feb 8, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 12, 1972	FmlNDA 16851 · New dosage form	Abbvie	41	Marketed
Sep 4, 1985	FmlNDA 17760 · New dosage form	Allergan	11	Discontinued
Feb 27, 1986	Fluor-OpANDA 70185	Novartis	7	Discontinued
Apr 23, 1986	Fml ForteNDA 19216 · New dosage form	Abbvie	24	Marketed
Jan 9, 2024	FluorometholoneANDA 216348	Amneal	0	Marketed
Feb 12, 2026	FluorometholoneANDA 218819	Sandoz	0	Marketed
—	OxyloneNDA 11748	Pharmacia And Upjohn	3	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA