🇺🇸 Yondelis in United States

FDA authorised Yondelis on 23 October 2015 · 758 US adverse-event reports

Marketing authorisations

FDA — authorised 23 October 2015

  • Application: NDA207953
  • Marketing authorisation holder: JANSSEN PRODS
  • 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. Pancytopenia — 97 reports (12.8%)
  2. Nausea — 92 reports (12.14%)
  3. Neutropenia — 91 reports (12.01%)
  4. Anaemia — 80 reports (10.55%)
  5. Rhabdomyolysis — 78 reports (10.29%)
  6. Alanine Aminotransferase Increased — 69 reports (9.1%)
  7. Thrombocytopenia — 69 reports (9.1%)
  8. Aspartate Aminotransferase Increased — 63 reports (8.31%)
  9. Off Label Use — 63 reports (8.31%)
  10. Vomiting — 56 reports (7.39%)

Source database →

Yondelis 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 Yondelis approved in United States?

Yes. FDA authorised it on 23 October 2015; FDA has authorised it.

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

JANSSEN PRODS holds the US marketing authorisation.