🇺🇸 Vitrase in United States

FDA authorised Vitrase on 5 May 2004 · 41 US adverse-event reports

Marketing authorisations

FDA — authorised 5 May 2004

  • Application: BLA021640
  • Marketing authorisation holder: BAUSCH AND LOMB
  • Status: supplemented

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. Drug Ineffective — 8 reports (19.51%)
  2. Burning Sensation — 5 reports (12.2%)
  3. Erythema — 5 reports (12.2%)
  4. Swelling Face — 5 reports (12.2%)
  5. Headache — 4 reports (9.76%)
  6. Chronic Kidney Disease — 3 reports (7.32%)
  7. Off Label Use — 3 reports (7.32%)
  8. Pain — 3 reports (7.32%)
  9. Renal Failure — 3 reports (7.32%)
  10. Acute Kidney Injury — 2 reports (4.88%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Vitrase approved in United States?

Yes. FDA authorised it on 5 May 2004; FDA has authorised it.

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

BAUSCH AND LOMB holds the US marketing authorisation.