🇺🇸 Abraxane in United States

FDA authorised Abraxane on 7 January 2005 · 9,791 US adverse-event reports

Marketing authorisations

FDA — authorised 7 January 2005

  • Application: NDA021660
  • Marketing authorisation holder: BRISTOL-MYERS
  • 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. Death — 2,309 reports (23.58%)
  2. Neutropenia — 946 reports (9.66%)
  3. Diarrhoea — 922 reports (9.42%)
  4. Nausea — 913 reports (9.32%)
  5. Anaemia — 868 reports (8.87%)
  6. Fatigue — 861 reports (8.79%)
  7. Pyrexia — 781 reports (7.98%)
  8. Off Label Use — 763 reports (7.79%)
  9. Vomiting — 715 reports (7.3%)
  10. Thrombocytopenia — 713 reports (7.28%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Abraxane approved in United States?

Yes. FDA authorised it on 7 January 2005; FDA has authorised it.

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

BRISTOL-MYERS holds the US marketing authorisation.