🇺🇸 Filgrastim-sndz in United States

FDA authorised Filgrastim-sndz on 6 March 2015 · 58 US adverse-event reports

Marketing authorisation

FDA — authorised 6 March 2015

  • Application: BLA125553
  • Marketing authorisation holder: SANDOZ INC
  • Local brand name: ZARXIO
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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. Cytokine Release Syndrome — 11 reports (18.97%)
  2. Febrile Neutropenia — 8 reports (13.79%)
  3. Neurotoxicity — 6 reports (10.34%)
  4. Fatigue — 5 reports (8.62%)
  5. Nausea — 5 reports (8.62%)
  6. Pancytopenia — 5 reports (8.62%)
  7. Pyrexia — 5 reports (8.62%)
  8. Vomiting — 5 reports (8.62%)
  9. Acute Kidney Injury — 4 reports (6.9%)
  10. Anaemia — 4 reports (6.9%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Filgrastim-sndz approved in United States?

Yes. FDA authorised it on 6 March 2015.

Who is the marketing authorisation holder for Filgrastim-sndz in United States?

SANDOZ INC holds the US marketing authorisation.