🇺🇸 Paclitaxel protein bound in United States

FDA authorised Paclitaxel protein bound on 7 January 2005 · 167 US adverse-event reports

Marketing authorisations

FDA — authorised 7 January 2005

  • Application: NDA021660
  • Marketing authorisation holder: BRISTOL-MYERS
  • Status: supplemented

FDA — authorised 27 July 2022

  • Application: NDA211875
  • Marketing authorisation holder: AM REGENT
  • Status: approved

FDA — authorised 10 April 2025

  • Application: ANDA209657
  • Marketing authorisation holder: CIPLA
  • Status: approved

FDA — authorised 15 May 2025

  • Application: ANDA216355
  • Marketing authorisation holder: SHUANGCHENG
  • 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. Asthenia — 21 reports (12.57%)
  2. Abdominal Pain — 20 reports (11.98%)
  3. Fatigue — 20 reports (11.98%)
  4. Pneumonia — 19 reports (11.38%)
  5. Pyrexia — 18 reports (10.78%)
  6. Diarrhoea — 17 reports (10.18%)
  7. Dyspnoea — 15 reports (8.98%)
  8. Nausea — 14 reports (8.38%)
  9. Vomiting — 12 reports (7.19%)
  10. Sepsis — 11 reports (6.59%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Paclitaxel protein bound approved in United States?

Yes. FDA authorised it on 7 January 2005; FDA authorised it on 27 July 2022; FDA authorised it on 10 April 2025.

Who is the marketing authorisation holder for Paclitaxel protein bound in United States?

BRISTOL-MYERS holds the US marketing authorisation.