FDA — authorised 16 June 2023
- Application: BLA761148
- Marketing authorisation holder: SPECTRUM PHARMS
- Indication: Labeling
- Status: approved
🇺🇸 ROLVEDON in United States
FDA authorised ROLVEDON on 16 June 2023
Marketing authorisation
ROLVEDON 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 ROLVEDON approved in United States?
Yes. FDA authorised it on 16 June 2023.
Who is the marketing authorisation holder for ROLVEDON in United States?
SPECTRUM PHARMS holds the US marketing authorisation.