FDA — authorised 11 May 2011
- Application: ANDA201211
- Marketing authorisation holder: COASTAL PHARMS
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 BROMFENAC SODIUM in United States
FDA authorised BROMFENAC SODIUM on 11 May 2011 · 132 US adverse-event reports
Marketing authorisations
FDA — authorised 9 January 2013
- Application: ANDA202030
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 January 2014
- Application: ANDA203395
- Marketing authorisation holder: SENTISS
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 23 June 2014
- Application: ANDA202620
- Marketing authorisation holder: APOTEX
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 February 2015
- Application: ANDA201941
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 April 2016
- Application: NDA206911
- Marketing authorisation holder: SUN PHARM
- Local brand name: BROMSITE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 June 2019
- Application: ANDA203368
- Marketing authorisation holder: RISING
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 June 2019
- Application: ANDA210560
- Marketing authorisation holder: ALEMBIC
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 March 2020
- Application: ANDA211029
- Marketing authorisation holder: GLAND
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 March 2022
- Application: ANDA204813
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 August 2023
- Application: ANDA202903
- Marketing authorisation holder: LUPIN
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 November 2023
- Application: ANDA206027
- Marketing authorisation holder: LUPIN
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 2 February 2024
- Application: ANDA211239
- Marketing authorisation holder: LUPIN
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA207334
- Marketing authorisation holder: APOTEX
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA214340
- Marketing authorisation holder: ALEMBIC
- Local brand name: BROMFENAC SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 132
Most-reported reactions
- Cataract — 23 reports (17.42%)
- Fall — 14 reports (10.61%)
- Fatigue — 14 reports (10.61%)
- Pneumonia — 13 reports (9.85%)
- Visual Acuity Reduced — 13 reports (9.85%)
- Nausea — 12 reports (9.09%)
- Diarrhoea — 11 reports (8.33%)
- Endophthalmitis — 11 reports (8.33%)
- Off Label Use — 11 reports (8.33%)
- Drug Ineffective — 10 reports (7.58%)
Frequently asked questions
Is BROMFENAC SODIUM approved in United States?
Yes. FDA authorised it on 11 May 2011; FDA authorised it on 9 January 2013; FDA authorised it on 22 January 2014.
Who is the marketing authorisation holder for BROMFENAC SODIUM in United States?
COASTAL PHARMS holds the US marketing authorisation.