🇺🇸 AZACITIDINE in United States

FDA authorised AZACITIDINE on 16 September 2013 · 13,285 US adverse-event reports

Marketing authorisations

FDA — authorised 16 September 2013

  • Application: ANDA201537
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 29 April 2016

  • Application: NDA208216
  • Marketing authorisation holder: ACTAVIS LLC
  • Status: supplemented

FDA — authorised 3 February 2022

  • Application: ANDA211549
  • Marketing authorisation holder: AMNEAL
  • Status: approved

FDA — authorised 30 December 2022

  • Application: ANDA215066
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: approved

FDA — authorised 28 June 2023

  • Application: ANDA215905
  • Marketing authorisation holder: JIANGSU HANSOH PHARM
  • 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. Febrile Neutropenia — 2,048 reports (15.42%)
  2. Death — 1,905 reports (14.34%)
  3. Off Label Use — 1,429 reports (10.76%)
  4. Acute Myeloid Leukaemia — 1,337 reports (10.06%)
  5. Neutropenia — 1,280 reports (9.63%)
  6. Myelosuppression — 1,203 reports (9.06%)
  7. Pneumonia — 1,134 reports (8.54%)
  8. Pyrexia — 1,014 reports (7.63%)
  9. Drug Ineffective — 974 reports (7.33%)
  10. Thrombocytopenia — 961 reports (7.23%)

Source database →

AZACITIDINE 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 AZACITIDINE approved in United States?

Yes. FDA authorised it on 16 September 2013; FDA authorised it on 29 April 2016; FDA authorised it on 3 February 2022.

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

DR REDDYS holds the US marketing authorisation.