🇺🇸 Clobetasol propionate cream in United States

FDA authorised Clobetasol propionate cream on 28 August 2020 · 153 US adverse-event reports

Marketing authorisation

FDA — authorised 28 August 2020

  • Application: ANDA212982
  • Marketing authorisation holder: ENCUBE
  • 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 — 51 reports (33.33%)
  2. Pruritus — 19 reports (12.42%)
  3. Off Label Use — 13 reports (8.5%)
  4. Burning Sensation — 12 reports (7.84%)
  5. Erythema — 12 reports (7.84%)
  6. Dry Skin — 11 reports (7.19%)
  7. Rash — 11 reports (7.19%)
  8. Product Use Issue — 9 reports (5.88%)
  9. Application Site Pain — 8 reports (5.23%)
  10. Headache — 7 reports (4.58%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is Clobetasol propionate cream approved in United States?

Yes. FDA authorised it on 28 August 2020.

Who is the marketing authorisation holder for Clobetasol propionate cream in United States?

ENCUBE holds the US marketing authorisation.