🇺🇸 Cytoxan in United States

FDA authorised Cytoxan on 29 April 1993 · 18,902 US adverse-event reports

Marketing authorisation

FDA — authorised 29 April 1993

  • Application: ANDA040015
  • Marketing authorisation holder: TEVA PARENTERAL
  • Local brand name: NEOSAR
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Alopecia — 5,370 reports (28.41%)
  2. Psychological Trauma — 2,219 reports (11.74%)
  3. Hair Texture Abnormal — 1,834 reports (9.7%)
  4. Hair Colour Changes — 1,830 reports (9.68%)
  5. Hair Disorder — 1,722 reports (9.11%)
  6. Madarosis — 1,563 reports (8.27%)
  7. Pain — 1,234 reports (6.53%)
  8. Anxiety — 1,207 reports (6.39%)
  9. Emotional Distress — 1,072 reports (5.67%)
  10. Impaired Quality Of Life — 851 reports (4.5%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Cytoxan approved in United States?

Yes. FDA authorised it on 29 April 1993.

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

TEVA PARENTERAL holds the US marketing authorisation.