FDA — authorised 1 September 2017
- Application: BLA761060
- Marketing authorisation holder: WYETH PHARMS INC
- Indication: Efficacy
- Status: approved
🇺🇸 GEMTUZUMAB OZOGAMICIN in United States
FDA authorised GEMTUZUMAB OZOGAMICIN on 1 September 2017
Marketing authorisation
GEMTUZUMAB OZOGAMICIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is GEMTUZUMAB OZOGAMICIN approved in United States?
Yes. FDA authorised it on 1 September 2017.
Who is the marketing authorisation holder for GEMTUZUMAB OZOGAMICIN in United States?
WYETH PHARMS INC holds the US marketing authorisation.