🇺🇸 DAUNORUBICIN in United States

FDA authorised DAUNORUBICIN on 30 January 1998 · 8,241 US adverse-event reports

Marketing authorisations

FDA — authorised 30 January 1998

  • Application: NDA050731
  • Marketing authorisation holder: HIKMA
  • Status: approved

FDA — authorised 24 January 2000

  • Application: ANDA065035
  • Marketing authorisation holder: MEITHEAL
  • Status: approved

FDA — authorised 12 April 2019

  • Application: ANDA208759
  • Marketing authorisation holder: HISUN PHARM HANGZHOU
  • 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. Febrile Neutropenia — 1,738 reports (21.09%)
  2. Pyrexia — 999 reports (12.12%)
  3. Neutropenia — 931 reports (11.3%)
  4. Sepsis — 884 reports (10.73%)
  5. Off Label Use — 691 reports (8.38%)
  6. Drug Ineffective — 654 reports (7.94%)
  7. Pneumonia — 652 reports (7.91%)
  8. Hypotension — 613 reports (7.44%)
  9. Thrombocytopenia — 560 reports (6.8%)
  10. Septic Shock — 519 reports (6.3%)

Source database →

DAUNORUBICIN 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 DAUNORUBICIN approved in United States?

Yes. FDA authorised it on 30 January 1998; FDA authorised it on 24 January 2000; FDA authorised it on 12 April 2019.

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

HIKMA holds the US marketing authorisation.