Bromfenac Sodium

Treats postoperative inflammation and reduction of ocular pain. Sold as Xibrom, Bromday, Prolensa, Bromsite. Every FDA application for this active ingredient: 3 branded and 16 generic.

As of Nov 15, 2026, FDA lists 19 applications for Bromfenac Sodium (sold as Xibrom, Bromday, Prolensa and others), first approved Mar 24, 2005, with 2 new uses approved and 0 published complete response letters.

First approved: Mar 24, 2005
Applications: 19
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $41.6M
First approved in the EU: May 18, 2011

Medicare Spending

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


Bromfenac Sodium	Part D	$29.0M	+25%	103,779
Prolensa	Part D	$12.2M	-73%	16,992
Bromsite	Part D	$465K	-67%	731

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

BROMFENAC SODIUM 0.07% EYE DRP: $13.30 per MLGeneric · -6% in a year
BROMFENAC SODIUM 0.09% EYE DRP: $15.09 per MLGeneric · -31% in a year
PROLENSA 0.07% EYE DROPS: $115.56 per MLBrand · +0% in a year
BROMSITE 0.075% EYE DROPS: $49.56 per MLBrand · 0% in a year

Approvals in the EU (EMA)

First approved in the EU 74 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Yellox, new substanceBausch + Lomb Ireland Limited · May 18, 2011

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract SurgeryMacular Oedema, Cataract Surgery · Nemocnice Kolín	Not applicable	Recruiting	Sep 17, 2025

Applications

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


Mar 24, 2005	Xibrom, BromdayNDA 21664 · New dosage form	Bausch And Lomb Inc	6	Discontinued
May 11, 2011	Bromfenac SodiumANDA 201211	Coastal Pharms	1	Discontinued
Jan 9, 2013	Bromfenac SodiumANDA 202030	J Molner	0	Discontinued
Apr 5, 2013	ProlensaNDA 203168 · New formulation or manufacturer	Bausch And Lomb	3	Marketed
Jan 22, 2014	Bromfenac SodiumANDA 203395	Sentiss	0	Marketed
Jun 19, 2014	Bromfenac SodiumANDA 202435	Apotex	0	Discontinued
Jun 23, 2014	Bromfenac SodiumANDA 202620	Apotex	0	Discontinued
Feb 10, 2015	Bromfenac SodiumANDA 201941	Chartwell Rx	0	Discontinued
Apr 8, 2016	BromsiteNDA 206911 · New formulation or manufacturer	Sun Pharm	1	Marketed
Jun 3, 2019	Bromfenac SodiumANDA 203368	Rising	0	Discontinued
Jun 21, 2019	Bromfenac SodiumANDA 210560	Alembic	0	Marketed
Mar 17, 2020	Bromfenac SodiumANDA 211029	Gland	0	Marketed
Mar 18, 2022	Bromfenac SodiumANDA 204813	Eugia Pharma	0	Marketed
Aug 15, 2023	Bromfenac SodiumANDA 202903	Lupin	0	Marketed
Nov 22, 2023	Bromfenac SodiumANDA 206027	Lupin	0	Marketed
Feb 2, 2024	Bromfenac SodiumANDA 211239	Lupin	0	Marketed
Jul 8, 2024	Bromfenac SodiumANDA 207334	Apotex	0	Marketed
Jul 8, 2024	Bromfenac SodiumANDA 214340	Alembic	0	Marketed
Jul 29, 2024	Bromfenac SodiumANDA 210962	Amneal	0	Marketed

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