🇺🇸 Darzalex in United States

FDA authorised Darzalex on 16 November 2015 · 13,648 US adverse-event reports

Marketing authorisations

FDA — authorised 16 November 2015

  • Application: BLA761036
  • Marketing authorisation holder: JANSSEN BIOTECH
  • Status: supplemented

FDA — authorised 1 May 2020

  • Application: BLA761145
  • Marketing authorisation holder: JANSSEN BIOTECH
  • 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. Plasma Cell Myeloma — 2,207 reports (16.17%)
  2. Infusion Related Reaction — 2,155 reports (15.79%)
  3. Off Label Use — 2,097 reports (15.36%)
  4. Fatigue — 1,295 reports (9.49%)
  5. Diarrhoea — 1,156 reports (8.47%)
  6. Pneumonia — 980 reports (7.18%)
  7. Death — 977 reports (7.16%)
  8. Dyspnoea — 936 reports (6.86%)
  9. Neutropenia — 929 reports (6.81%)
  10. Neuropathy Peripheral — 916 reports (6.71%)

Source database →

Darzalex in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Darzalex approved in United States?

Yes. FDA authorised it on 16 November 2015; FDA authorised it on 1 May 2020; FDA has authorised it.

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

JANSSEN BIOTECH holds the US marketing authorisation.