FDA — authorised 23 October 2015
- Marketing authorisation holder: JANSSEN PRODS
- Status: approved
🇺🇸 Yondelis in United States
FDA authorised Yondelis on 23 October 2015
Marketing authorisations
FDA — authorised 28 December 2018
- Application: NDA207953
- Marketing authorisation holder: JANSSEN PRODS
- Indication: Labeling
- Status: approved
Yondelis 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 Yondelis approved in United States?
Yes. FDA authorised it on 23 October 2015; FDA authorised it on 28 December 2018.
Who is the marketing authorisation holder for Yondelis in United States?
JANSSEN PRODS holds the US marketing authorisation.