FDA — authorised 9 September 2022
- Marketing authorisation holder: SPECTRUM PHARMS
- Status: approved
🇺🇸 Rolvedon in United States
FDA authorised Rolvedon on 9 September 2022
Marketing authorisations
FDA — authorised 9 September 2022
- Application: BLA761148
- Marketing authorisation holder: SPECTRUM PHARMS
- Local brand name: ROLVEDON
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
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 9 September 2022; FDA authorised it on 9 September 2022.
Who is the marketing authorisation holder for Rolvedon in United States?
SPECTRUM PHARMS holds the US marketing authorisation.