FDA — authorised 16 October 2018
- Marketing authorisation holder: PFIZER INC
- Status: approved
🇺🇸 Talzenna in United States
FDA authorised Talzenna on 16 October 2018
Marketing authorisations
FDA — authorised 7 March 2024
- Application: NDA217439
- Marketing authorisation holder: PFIZER
- Local brand name: TALZENNA
- Indication: CAPSULE — ORAL
- Status: approved
Talzenna 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 Talzenna approved in United States?
Yes. FDA authorised it on 16 October 2018; FDA authorised it on 7 March 2024.
Who is the marketing authorisation holder for Talzenna in United States?
PFIZER INC holds the US marketing authorisation.