FDA — authorised 21 September 2018
- Marketing authorisation holder: PFIZER INC
- Status: approved
🇺🇸 Lorbrena in United States
FDA authorised Lorbrena on 21 September 2018
Marketing authorisations
FDA — authorised 26 February 2021
- Application: NDA210868
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
Lorbrena 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 Lorbrena approved in United States?
Yes. FDA authorised it on 21 September 2018; FDA authorised it on 26 February 2021.
Who is the marketing authorisation holder for Lorbrena in United States?
PFIZER INC holds the US marketing authorisation.