🇺🇸 Zepzelca in United States

FDA authorised Zepzelca on 15 June 2020 · 375 US adverse-event reports

Marketing authorisations

FDA — authorised 15 June 2020

  • Application: NDA213702
  • Marketing authorisation holder: JAZZ
  • 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. Disease Progression — 64 reports (17.07%)
  2. Death — 62 reports (16.53%)
  3. Off Label Use — 51 reports (13.6%)
  4. Nausea — 40 reports (10.67%)
  5. Fatigue — 32 reports (8.53%)
  6. Neutropenia — 29 reports (7.73%)
  7. Injection Site Reaction — 28 reports (7.47%)
  8. Thrombocytopenia — 24 reports (6.4%)
  9. Vomiting — 24 reports (6.4%)
  10. Asthenia — 21 reports (5.6%)

Source database →

Zepzelca 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 Zepzelca approved in United States?

Yes. FDA authorised it on 15 June 2020; FDA has authorised it.

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

JAZZ holds the US marketing authorisation.