FDA — authorised 20 September 2021
- Application: BLA761208
- Marketing authorisation holder: SEAGEN
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Tivdak in United States
FDA authorised Tivdak on 20 September 2021
Marketing authorisations
FDA
- Marketing authorisation holder: SEAGEN
- Status: approved
Tivdak 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 Tivdak approved in United States?
Yes. FDA authorised it on 20 September 2021; FDA has authorised it.
Who is the marketing authorisation holder for Tivdak in United States?
SEAGEN holds the US marketing authorisation.