🇺🇸 bromfenac ophthalmic solution in United States

FDA authorised bromfenac ophthalmic solution on 5 April 2013 · 45 US adverse-event reports

Marketing authorisations

FDA — authorised 5 April 2013

  • Application: NDA203168
  • Marketing authorisation holder: BAUSCH AND LOMB
  • Status: supplemented

FDA — authorised 21 June 2019

  • Application: ANDA210560
  • Marketing authorisation holder: ALEMBIC
  • Status: approved

FDA — authorised 8 July 2024

  • Application: ANDA207334
  • Marketing authorisation holder: APOTEX
  • 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.

Most-reported reactions

  1. Eye Irritation — 8 reports (17.78%)
  2. Eye Pain — 6 reports (13.33%)
  3. Drug Ineffective — 5 reports (11.11%)
  4. Product Dose Omission Issue — 5 reports (11.11%)
  5. Off Label Use — 4 reports (8.89%)
  6. Product Packaging Quantity Issue — 4 reports (8.89%)
  7. Vision Blurred — 4 reports (8.89%)
  8. Cystoid Macular Oedema — 3 reports (6.67%)
  9. Eye Swelling — 3 reports (6.67%)
  10. Product Use In Unapproved Indication — 3 reports (6.67%)

Source database →

bromfenac ophthalmic solution in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is bromfenac ophthalmic solution approved in United States?

Yes. FDA authorised it on 5 April 2013; FDA authorised it on 21 June 2019; FDA authorised it on 8 July 2024.

Who is the marketing authorisation holder for bromfenac ophthalmic solution in United States?

BAUSCH AND LOMB holds the US marketing authorisation.