FDA — authorised 17 August 2017
- Application: BLA761040
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: BESPONSA
- Indication: POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
- Status: approved
🇺🇸 Inotuzumab ozogamicin-dose level 1 in United States
FDA authorised Inotuzumab ozogamicin-dose level 1 on 17 August 2017
Marketing authorisation
Inotuzumab ozogamicin-dose level 1 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 Inotuzumab ozogamicin-dose level 1 approved in United States?
Yes. FDA authorised it on 17 August 2017.
Who is the marketing authorisation holder for Inotuzumab ozogamicin-dose level 1 in United States?
WYETH PHARMS INC holds the US marketing authorisation.