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XIBROM

NDA

BROMFENAC SODIUM | N021664 | BAUSCH AND LOMB INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4359 · 11 docket documents Pharmobedient Consulting, LLC submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bromfenac Solution/Drops, 0.08% suitable for submission in an Abbreviated New Drug Application, representing a strength change from th	Suitability	2023-10-05	Denied	Pharmobedient Consulting, LLC
Citizen Petition From Regcon Solutions LLC FDA-2015-P-2962 · 4 docket documents Regcon Solutions LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Hi-Tech Pharmacal's Bromfenac Sodium ophthalmic solution 0.09% acid (ANDA 203395) as a second reference listed drug, since the	505(q)	2015-08-12	Withdrawn	Regcon Solutions LLC
ISTA Pharmaceuticals, Inc. (Covington & Burling LLP) - Citizen Petition FDA-2011-P-0128 · 5 docket documents ISTA Pharmaceuticals, Inc. filed this citizen petition under 21 C.F.R. § 10.30 to request that the FDA refrain from granting tentative or final approval of any ANDA for bromfenac ophthalmic solution 0.09% that uses the discontinued XIBROM labeling with twice-daily dosing or omits the once-daily dosi	505(q)	2011-03-09	Granted	—
Citizen Petition from ISTA Pharmaceuticals, Inc., (Covington & Burling LLP) FDA-2010-P-0625 · 3 docket documents ISTA Pharmaceuticals, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA consider that bromfenac ophthalmic solution 0.09% with once-daily dosing (BROMDAY) is safer than the higher twice-daily dose formulation (XIBROM) and should be	505(q) Stay Request	2011-02-15	Withdrawn	ISTA Pharmaceuticals, Inc., (Covington & Burling LLP)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

38 trials from ClinicalTrials.gov, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase NCT00520260	Phase 4	Completed	Florida Eye Microsurgical Institute	42	2007-08 → 2008-08
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients NCT00347503	Phase 4	Completed	Innovative Medical	—	—
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery NCT01847638	N/A	Completed	Melissa Toyos	50	2013-04-01 → 2018-08-23
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery NCT00704418	Phase 3	Completed	Bausch & Lomb Incorporated	156	2008-06 → 2009-12
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery NCT00853970	Phase 3	Completed	Bausch & Lomb Incorporated	299	2009-02 → 2009-12
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification NCT01001806	Phase 4	Completed	Frank A. Bucci, Jr., M.D.	126	2009-10 → 2010-01
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)NCT01023724	Phase 4	Completed	Bucci Laser Vision Institute	50	2009-12 → 2010-02
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.NCT01535443	Phase 1	Completed	Laboratorios Sophia S.A de C.V.	35	2011-09 → 2011-10
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease NCT01212471	Phase 3	Completed	Bausch & Lomb Incorporated	840	2010-09 → 2011-12
PRevention of Macular EDema After Cataract Surgery NCT01774474	Phase 3	Completed	Maastricht University Medical Center	1,127	2013-07-10 → 2016-11-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 28, 2014	SUPPL -14	View Letter (PDF)
Jan 28, 2014	SUPPL -19	View Letter (PDF)
Oct 19, 2010	SUPPL -13	View Letter (PDF)
Jun 8, 2009	SUPPL -10	View Letter (PDF)
Jan 30, 2006	SUPPL -1	View Letter (PDF)
Mar 29, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#002 — EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 16, 2010

#001 — EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 24, 2005

No patent or exclusivity listings for this strength.