🇺🇸 Hycamtin in United States

FDA authorised Hycamtin on 28 May 1996 · 1,486 US adverse-event reports

Marketing authorisations

FDA — authorised 28 May 1996

  • Application: NDA020671
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 11 October 2007

  • Application: NDA020981
  • Marketing authorisation holder: SANDOZ
  • 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 — 371 reports (24.97%)
  2. Anaemia — 168 reports (11.31%)
  3. Nausea — 161 reports (10.83%)
  4. White Blood Cell Count Decreased — 160 reports (10.77%)
  5. Platelet Count Decreased — 143 reports (9.62%)
  6. Neutrophil Count Decreased — 111 reports (7.47%)
  7. Fatigue — 100 reports (6.73%)
  8. Thrombocytopenia — 95 reports (6.39%)
  9. Decreased Appetite — 89 reports (5.99%)
  10. Neutropenia — 88 reports (5.92%)

Source database →

Hycamtin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Hycamtin approved in United States?

Yes. FDA authorised it on 28 May 1996; FDA authorised it on 11 October 2007; FDA has authorised it.

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

SANDOZ holds the US marketing authorisation.