🇺🇸 Santyl in United States

FDA authorised Santyl on 4 June 1965 · 1,010 US adverse-event reports

Marketing authorisations

FDA — authorised 4 June 1965

  • Application: BLA101995
  • Marketing authorisation holder: SMITH AND NEPHEW
  • 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. Death — 279 reports (27.62%)
  2. Wound Complication — 156 reports (15.45%)
  3. Drug Ineffective — 117 reports (11.58%)
  4. Application Site Pain — 110 reports (10.89%)
  5. Off Label Use — 67 reports (6.63%)
  6. Pain — 66 reports (6.53%)
  7. Impaired Healing — 57 reports (5.64%)
  8. Wound — 54 reports (5.35%)
  9. Acute Kidney Injury — 52 reports (5.15%)
  10. Chronic Kidney Disease — 52 reports (5.15%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Santyl approved in United States?

Yes. FDA authorised it on 4 June 1965; FDA has authorised it.

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

SMITH AND NEPHEW holds the US marketing authorisation.