FDA — authorised 15 June 2020
- Marketing authorisation holder: JAZZ
- Status: approved
🇺🇸 Zepzelca in United States
FDA authorised Zepzelca on 15 June 2020
Marketing authorisations
FDA — authorised 15 June 2020
- Application: NDA213702
- Marketing authorisation holder: JAZZ
- Local brand name: ZEPZELCA
- Indication: POWDER — INTRAVENOUS
- Status: approved
The FDA approved Zepzelca, developed by JAZZ, for the treatment of adult patients with small cell lung cancer. This approval was granted on 2 October 2025, following a standard expedited pathway. The application number for this approval is NDA213702.
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 authorised it on 15 June 2020.
Who is the marketing authorisation holder for Zepzelca in United States?
JAZZ holds the US marketing authorisation.