FDA — authorised 17 May 2000
- Marketing authorisation holder: WYETH PHARMS INC
- Status: approved
🇺🇸 Mylotarg in United States
FDA authorised Mylotarg on 17 May 2000
Marketing authorisations
FDA — authorised 1 September 2017
- Application: BLA761060
- Marketing authorisation holder: WYETH PHARMS INC
- Indication: Efficacy
- Status: approved
Mylotarg 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 Mylotarg approved in United States?
Yes. FDA authorised it on 17 May 2000; FDA authorised it on 1 September 2017.
Who is the marketing authorisation holder for Mylotarg in United States?
WYETH PHARMS INC holds the US marketing authorisation.