🇺🇸 differin in United States

FDA authorised differin on 31 May 1996 · 7,401 US adverse-event reports

Marketing authorisations

FDA — authorised 31 May 1996

  • Application: NDA020380
  • Marketing authorisation holder: GALDERMA LABS LP
  • Status: supplemented

FDA — authorised 26 May 2000

  • Application: NDA020748
  • Marketing authorisation holder: GALDERMA LABS LP
  • Status: approved

FDA — authorised 19 June 2007

  • Application: NDA021753
  • Marketing authorisation holder: GALDERMA LABS LP
  • 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. Dry Skin — 1,421 reports (19.2%)
  2. Acne — 1,049 reports (14.17%)
  3. Drug Ineffective — 1,040 reports (14.05%)
  4. Skin Burning Sensation — 806 reports (10.89%)
  5. Skin Exfoliation — 740 reports (10%)
  6. Erythema — 733 reports (9.9%)
  7. Skin Irritation — 503 reports (6.8%)
  8. Pain Of Skin — 410 reports (5.54%)
  9. Pruritus — 351 reports (4.74%)
  10. Product Use In Unapproved Indication — 348 reports (4.7%)

Source database →

differin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Dermatology approved in United States

Frequently asked questions

Is differin approved in United States?

Yes. FDA authorised it on 31 May 1996; FDA authorised it on 26 May 2000; FDA authorised it on 19 June 2007.

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

GALDERMA LABS LP holds the US marketing authorisation.