FDA — authorised 2 November 2018
- Application: NDA210868
- Marketing authorisation holder: PFIZER
- Local brand name: LORBRENA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lorbrena in United States
FDA authorised Lorbrena on 2 November 2018
Marketing authorisation
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 2 November 2018.
Who is the marketing authorisation holder for Lorbrena in United States?
PFIZER holds the US marketing authorisation.