FDA — authorised 3 February 2015
- Application: NDA207103
- Marketing authorisation holder: PFIZER
- Local brand name: IBRANCE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Palbocicilib in United States
FDA authorised Palbocicilib on 3 February 2015
Marketing authorisations
FDA — authorised 1 November 2019
- Application: NDA212436
- Marketing authorisation holder: PFIZER
- Local brand name: IBRANCE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Palbocicilib in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Palbocicilib approved in United States?
Yes. FDA authorised it on 3 February 2015; FDA authorised it on 1 November 2019; FDA has authorised it.
Who is the marketing authorisation holder for Palbocicilib in United States?
PFIZER holds the US marketing authorisation.