FDA — authorised 9 August 2023
- Application: BLA761342
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: TALVEY
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Talvey in United States
FDA authorised Talvey on 9 August 2023
Marketing authorisation
Talvey 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 Talvey approved in United States?
Yes. FDA authorised it on 9 August 2023.
Who is the marketing authorisation holder for Talvey in United States?
JANSSEN BIOTECH holds the US marketing authorisation.