🇺🇸 Gatifloxacin Ophthalmic in United States

FDA authorised Gatifloxacin Ophthalmic on 3 November 2021 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 3 November 2021

  • Application: ANDA213542
  • Marketing authorisation holder: CAPLIN
  • 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. Dizziness — 2 reports (18.18%)
  2. Balance Disorder — 1 report (9.09%)
  3. Cataract — 1 report (9.09%)
  4. Depression — 1 report (9.09%)
  5. Disorientation — 1 report (9.09%)
  6. Dyspnoea — 1 report (9.09%)
  7. Electrolyte Imbalance — 1 report (9.09%)
  8. Eye Irritation — 1 report (9.09%)
  9. Eye Pain — 1 report (9.09%)
  10. Fatigue — 1 report (9.09%)

Source database →

Gatifloxacin 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 Gatifloxacin Ophthalmic approved in United States?

Yes. FDA authorised it on 3 November 2021; FDA has authorised it.

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

CAPLIN holds the US marketing authorisation.