FDA — authorised 27 November 2023
- Application: NDA217677
- Marketing authorisation holder: SPRINGWORKS
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Ogsiveo in United States
FDA authorised Ogsiveo on 27 November 2023
Marketing authorisations
FDA
- Marketing authorisation holder: SPRINGWORKS
- Status: approved
Ogsiveo 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 Ogsiveo approved in United States?
Yes. FDA authorised it on 27 November 2023; FDA has authorised it.
Who is the marketing authorisation holder for Ogsiveo in United States?
SPRINGWORKS holds the US marketing authorisation.