FDA — authorised 16 June 2021
- Application: NDA211651
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
🇺🇸 Talzenna in United States
FDA authorised Talzenna on 16 June 2021
Marketing authorisations
FDA — authorised 7 March 2024
- Application: NDA217439
- Marketing authorisation holder: PFIZER
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The US FDA approved Talzenna, a new formulation or new manufacturer of the drug, on 7 March 2024. The marketing authorisation holder is Pfizer. This approval was granted under the standard expedited pathway. The application number for this approval is NDA217439.
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 June 2021; FDA authorised it on 7 March 2024.
Who is the marketing authorisation holder for Talzenna in United States?
PFIZER holds the US marketing authorisation.