🇺🇸 PEMETREXED in United States

FDA authorised PEMETREXED on 21 August 2020 · 12,163 US adverse-event reports

Marketing authorisations

FDA — authorised 21 August 2020

  • Application: NDA208419
  • Marketing authorisation holder: ACTAVIS
  • Status: supplemented

FDA — authorised 25 May 2022

  • Application: ANDA203774
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 25 May 2022

  • Application: ANDA204890
  • Marketing authorisation holder: QILU PHARM HAINAN
  • Status: supplemented

FDA — authorised 25 May 2022

  • Application: ANDA209851
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 22 June 2022

  • Application: NDA214218
  • Marketing authorisation holder: HOSPIRA
  • 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. Malignant Neoplasm Progression — 2,055 reports (16.9%)
  2. Anaemia — 1,396 reports (11.48%)
  3. Nausea — 1,187 reports (9.76%)
  4. Diarrhoea — 1,151 reports (9.46%)
  5. Disease Progression — 1,149 reports (9.45%)
  6. Neutropenia — 1,126 reports (9.26%)
  7. Off Label Use — 1,116 reports (9.18%)
  8. Pancytopenia — 1,021 reports (8.39%)
  9. Thrombocytopenia — 1,011 reports (8.31%)
  10. Drug Ineffective — 951 reports (7.82%)

Source database →

PEMETREXED 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 PEMETREXED approved in United States?

Yes. FDA authorised it on 21 August 2020; FDA authorised it on 25 May 2022; FDA authorised it on 25 May 2022.

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

ACTAVIS holds the US marketing authorisation.