FDA — authorised 27 January 2023
- Marketing authorisation holder: STEMLINE THERAPEUTICS INC
- Status: approved
🇺🇸 Orserdu in United States
FDA authorised Orserdu on 27 January 2023
Marketing authorisations
FDA — authorised 27 January 2023
- Application: NDA217639
- Marketing authorisation holder: STEMLINE THERAP
- Indication: Type 1 - New Molecular Entity
- Status: approved
Orserdu 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 Orserdu approved in United States?
Yes. FDA authorised it on 27 January 2023; FDA authorised it on 27 January 2023.
Who is the marketing authorisation holder for Orserdu in United States?
STEMLINE THERAPEUTICS INC holds the US marketing authorisation.