🇺🇸 Istodax in United States

FDA authorised Istodax on 5 November 2009 · 638 US adverse-event reports

Marketing authorisations

FDA — authorised 5 November 2009

  • Application: NDA022393
  • Marketing authorisation holder: BRISTOL-MYERS
  • 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. Peripheral T-Cell Lymphoma Unspecified — 102 reports (15.99%)
  2. Death — 98 reports (15.36%)
  3. Thrombocytopenia — 73 reports (11.44%)
  4. Nausea — 66 reports (10.34%)
  5. Platelet Count Decreased — 63 reports (9.87%)
  6. Product Storage Error — 57 reports (8.93%)
  7. Pyrexia — 54 reports (8.46%)
  8. Anaemia — 43 reports (6.74%)
  9. Vomiting — 42 reports (6.58%)
  10. Fatigue — 40 reports (6.27%)

Source database →

Istodax 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 Istodax approved in United States?

Yes. FDA authorised it on 5 November 2009; FDA has authorised it.

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

BRISTOL-MYERS holds the US marketing authorisation.