🇺🇸 Moxifloxacin Ophthalmic in United States

FDA authorised Moxifloxacin Ophthalmic on 15 April 2003 · 29 US adverse-event reports

Marketing authorisations

FDA — authorised 15 April 2003

  • Application: NDA021598
  • Marketing authorisation holder: HARROW EYE
  • Status: approved

FDA — authorised 13 February 2019

  • Application: ANDA209469
  • Marketing authorisation holder: ALEMBIC
  • Status: supplemented

FDA — authorised 30 March 2020

  • Application: ANDA208778
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 27 January 2025

  • Application: ANDA217988
  • Marketing authorisation holder: MANKIND PHARMA
  • 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 Pain — 5 reports (17.24%)
  2. Off Label Use — 5 reports (17.24%)
  3. Drug Ineffective — 4 reports (13.79%)
  4. Fatigue — 3 reports (10.34%)
  5. Asthenia — 2 reports (6.9%)
  6. Corneal Opacity — 2 reports (6.9%)
  7. Diarrhoea — 2 reports (6.9%)
  8. Eye Irritation — 2 reports (6.9%)
  9. Eye Swelling — 2 reports (6.9%)
  10. Hyperhidrosis — 2 reports (6.9%)

Source database →

Moxifloxacin Ophthalmic 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 Moxifloxacin Ophthalmic approved in United States?

Yes. FDA authorised it on 15 April 2003; FDA authorised it on 13 February 2019; FDA authorised it on 30 March 2020.

Who is the marketing authorisation holder for Moxifloxacin Ophthalmic in United States?

HARROW EYE holds the US marketing authorisation.