🇺🇸 DuraPrep in United States

FDA authorised DuraPrep on 29 September 2006 · 201 US adverse-event reports

Marketing authorisations

FDA — authorised 29 September 2006

  • Application: NDA021586
  • Marketing authorisation holder: 3M
  • 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. Thermal Burn — 37 reports (18.41%)
  2. Skin Irritation — 36 reports (17.91%)
  3. Blister — 34 reports (16.92%)
  4. Pruritus — 20 reports (9.95%)
  5. Rash — 19 reports (9.45%)
  6. Skin Reaction — 16 reports (7.96%)
  7. Skin Exfoliation — 11 reports (5.47%)
  8. Excoriation — 10 reports (4.98%)
  9. Caustic Injury — 9 reports (4.48%)
  10. Skin Disorder — 9 reports (4.48%)

Source database →

DuraPrep 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 DuraPrep approved in United States?

Yes. FDA authorised it on 29 September 2006; FDA has authorised it.

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

3M holds the US marketing authorisation.