🇺🇸 TAPINAROF in United States

FDA authorised TAPINAROF on 12 December 2024 · 879 US adverse-event reports

Marketing authorisation

FDA — authorised 12 December 2024

  • Application: NDA215272
  • Marketing authorisation holder: ORGANON LLC
  • Indication: Efficacy
  • Status: approved

The FDA approved TAPINAROF, a drug developed by ORGANON LLC, on 12 December 2024. The approval was granted under the standard expedited pathway, with application number NDA215272. The approved indication for TAPINAROF is based on its demonstrated efficacy.

Read official source →

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. Folliculitis — 235 reports (26.73%)
  2. Pruritus — 121 reports (13.77%)
  3. Dermatitis Contact — 97 reports (11.04%)
  4. Headache — 95 reports (10.81%)
  5. Rash — 81 reports (9.22%)
  6. Skin Burning Sensation — 64 reports (7.28%)
  7. Erythema — 61 reports (6.94%)
  8. Drug Ineffective — 45 reports (5.12%)
  9. Application Site Erythema — 40 reports (4.55%)
  10. Pain Of Skin — 40 reports (4.55%)

Source database →

TAPINAROF 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 TAPINAROF approved in United States?

Yes. FDA authorised it on 12 December 2024.

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

ORGANON LLC holds the US marketing authorisation.