🇺🇸 BiCNU in United States

FDA authorised BiCNU on 7 March 1977 · 503 US adverse-event reports

Marketing authorisation

FDA — authorised 7 March 1977

  • Application: NDA017422
  • Marketing authorisation holder: AVET LIFESCIENCES
  • Local brand name: BICNU
  • 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. Myelodysplastic Syndrome — 60 reports (11.93%)
  2. Off Label Use — 60 reports (11.93%)
  3. Haematotoxicity — 58 reports (11.53%)
  4. Febrile Neutropenia — 57 reports (11.33%)
  5. Diarrhoea — 53 reports (10.54%)
  6. Acute Myeloid Leukaemia — 47 reports (9.34%)
  7. Thrombocytopenia — 45 reports (8.95%)
  8. Pyrexia — 42 reports (8.35%)
  9. Mucosal Inflammation — 41 reports (8.15%)
  10. Second Primary Malignancy — 40 reports (7.95%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is BiCNU approved in United States?

Yes. FDA authorised it on 7 March 1977.

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

AVET LIFESCIENCES holds the US marketing authorisation.