🇺🇸 Altreno in United States

FDA authorised Altreno on 23 August 2018 · 50 US adverse-event reports

Marketing authorisations

FDA — authorised 23 August 2018

  • Application: NDA209353
  • Marketing authorisation holder: DOW PHARM
  • Local brand name: ALTRENO
  • Indication: LOTION — TOPICAL
  • Status: approved

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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. Product Use In Unapproved Indication — 8 reports (16%)
  2. Application Site Erythema — 7 reports (14%)
  3. Dry Skin — 7 reports (14%)
  4. Erythema — 6 reports (12%)
  5. Skin Exfoliation — 6 reports (12%)
  6. Drug Ineffective — 5 reports (10%)
  7. Fatigue — 3 reports (6%)
  8. Product Quality Issue — 3 reports (6%)
  9. Skin Irritation — 3 reports (6%)
  10. Accidental Exposure To Product — 2 reports (4%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Altreno approved in United States?

Yes. FDA authorised it on 23 August 2018; FDA has authorised it.

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

DOW PHARM holds the US marketing authorisation.