Yellox Bausch + Lomb Ireland Limited · Authorised · authorised 18 May 2011 · ATC S01BC11
Therapeutic indication (EMA)
Treatment of postoperative ocular inflammation following cataract extraction in adults.
Active substance
Bromfenac
- SFDA 1
- US FDA 20
- EMA 1
- Health Canada 3
- US price lines 5
- NHS prices 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BROFIX 0.09% eye drops solution | 0.09 % | Eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 58.65 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
Indications — CHI Daman Drug Formulary
ALLERGIC CONJUCTIVITIS (AC); CYSTOID MACULAR EDEMA; NON-INFECTIOUS UVEITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROLENSA | EQ 0.07% ACID | solution/drops · ophthalmic | BAUSCH AND LOMB | Prescription | 5 Apr 2013 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | SENTISS | Prescription | 22 Jan 2014 |
| BROMSITE | EQ 0.075% ACID | solution/drops · ophthalmic | SUN PHARM | Prescription | 8 Apr 2016 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | ALEMBIC | Prescription | 21 Jun 2019 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | GLAND | Prescription | 17 Mar 2020 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | EUGIA PHARMA | Prescription | 18 Mar 2022 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | LUPIN | Prescription | 15 Aug 2023 |
| BROMFENAC SODIUM | EQ 0.07% ACID | solution/drops · ophthalmic | LUPIN | Prescription | 22 Nov 2023 |
| BROMFENAC SODIUM | EQ 0.075% ACID | solution/drops · ophthalmic | LUPIN | Prescription | 2 Feb 2024 |
| BROMFENAC SODIUM | EQ 0.07% ACID | solution/drops · ophthalmic | APOTEX | Prescription | 8 Jul 2024 |
| BROMFENAC SODIUM | EQ 0.07% ACID | solution/drops · ophthalmic | ALEMBIC | Prescription | 8 Jul 2024 |
| BROMFENAC SODIUM | EQ 0.07% ACID | solution/drops · ophthalmic | AMNEAL | Prescription | 29 Jul 2024 |
| XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Discontinued | 24 Mar 2005 |
| BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Discontinued | 24 Mar 2005 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | COASTAL PHARMS | Discontinued | 11 May 2011 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | J MOLNER | Discontinued | 9 Jan 2013 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | APOTEX | Discontinued | 19 Jun 2014 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | APOTEX | Discontinued | 23 Jun 2014 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | CHARTWELL RX | Discontinued | 10 Feb 2015 |
| BROMFENAC SODIUM | EQ 0.09% ACID | solution/drops · ophthalmic | RISING | Discontinued | 3 Jun 2019 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-BROMFENAC | 02537788 | 0.07 % / W/V | SOLUTION · OPHTHALMIC | APOTEX INC |
| AURO-BROMFENAC | 02540789 | 0.07 % / W/V | SOLUTION · OPHTHALMIC | AURO PHARMA INC |
| PROLENSA | 02439123 | 0.07 % / W/V | SOLUTION · OPHTHALMIC | BAUSCH & LOMB INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BROMFENAC SOD 0.075% EYE DROP | $24.38477 | per ML | 23 Sep 2026 |
| US NADAC | BROMFENAC SODIUM 0.07% EYE DRP | $13.24968 | per ML | 23 Sep 2026 |
| US NADAC | BROMFENAC SODIUM 0.09% EYE DRP | $15.63411 | per ML | 23 Sep 2026 |
| US NADAC | BROMSITE 0.075% EYE DROPS | $49.55344 | per ML | 23 Sep 2026 |
| US NADAC | PROLENSA 0.07% EYE DROPS | $115.55435 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Bromfenac 900micrograms/ml eye drops | £8.50 | 5 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 18 Feb 2025 PROLENSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.