🇺🇸 IRINOTECAN in United States

FDA authorised IRINOTECAN on 20 December 2010 · 27,791 US adverse-event reports

Marketing authorisations

FDA — authorised 20 December 2010

  • Application: ANDA091032
  • Marketing authorisation holder: HIKMA FARMACEUTICA
  • Status: supplemented

FDA — authorised 16 December 2011

  • Application: ANDA090675
  • Marketing authorisation holder: HENGRUI PHARMA
  • Status: supplemented

FDA — authorised 3 May 2016

  • Application: ANDA203380
  • Marketing authorisation holder: QILU PHARM HAINAN
  • Status: approved

FDA — authorised 26 May 2017

  • Application: ANDA206935
  • Marketing authorisation holder: NOVAST LABS
  • Status: supplemented

FDA — authorised 18 November 2019

  • Application: ANDA212993
  • Marketing authorisation holder: GLAND
  • Status: approved

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. Diarrhoea — 5,766 reports (20.75%)
  2. Neutropenia — 3,339 reports (12.01%)
  3. Nausea — 3,170 reports (11.41%)
  4. Disease Progression — 2,867 reports (10.32%)
  5. Vomiting — 2,759 reports (9.93%)
  6. Off Label Use — 2,660 reports (9.57%)
  7. Fatigue — 1,992 reports (7.17%)
  8. Febrile Neutropenia — 1,833 reports (6.6%)
  9. Thrombocytopenia — 1,708 reports (6.15%)
  10. Death — 1,697 reports (6.11%)

Source database →

IRINOTECAN in other countries

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

Frequently asked questions

Is IRINOTECAN approved in United States?

Yes. FDA authorised it on 20 December 2010; FDA authorised it on 16 December 2011; FDA authorised it on 3 May 2016.

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

HIKMA FARMACEUTICA holds the US marketing authorisation.