FDA — authorised 22 October 2015
- Application: NDA207793
- Marketing authorisation holder: IPSEN
- Local brand name: ONIVYDE
- Indication: INJECTABLE, LIPOSOMAL — INTRAVENOUS
- Status: approved
🇺🇸 Camptosar in United States
FDA authorised Camptosar on 22 October 2015
Marketing authorisations
FDA
- Status: approved
Camptosar 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 Camptosar approved in United States?
Yes. FDA authorised it on 22 October 2015; FDA has authorised it.
Who is the marketing authorisation holder for Camptosar in United States?
IPSEN holds the US marketing authorisation.