🇺🇸 Cequa in United States

FDA authorised Cequa on 14 August 2018 · 4,100 US adverse-event reports

Marketing authorisations

FDA — authorised 14 August 2018

  • Application: NDA210913
  • Marketing authorisation holder: SUN PHARM
  • 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 — 1,400 reports (34.15%)
  2. Eye Pain — 550 reports (13.41%)
  3. Drug Ineffective — 385 reports (9.39%)
  4. Therapy Cessation — 362 reports (8.83%)
  5. Product Use Issue — 346 reports (8.44%)
  6. Product Dose Omission Issue — 265 reports (6.46%)
  7. Ocular Hyperaemia — 247 reports (6.02%)
  8. Lacrimation Increased — 203 reports (4.95%)
  9. Product Storage Error — 180 reports (4.39%)
  10. Vision Blurred — 162 reports (3.95%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Cequa approved in United States?

Yes. FDA authorised it on 14 August 2018; FDA has authorised it.

Who is the marketing authorisation holder for Cequa in United States?

SUN PHARM holds the US marketing authorisation.