FDA — authorised 1 September 2015
- Marketing authorisation holder: TESARO INC
- Status: approved
🇺🇸 Varubi in United States
FDA authorised Varubi on 1 September 2015
Marketing authorisations
FDA — authorised 1 September 2015
- Application: NDA206500
- Marketing authorisation holder: TERSERA
- Local brand name: VARUBI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2017
- Application: NDA208399
- Marketing authorisation holder: TERSERA
- Local brand name: VARUBI
- Indication: EMULSION — INTRAVENOUS
- Status: approved
Varubi 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 Varubi approved in United States?
Yes. FDA authorised it on 1 September 2015; FDA authorised it on 1 September 2015; FDA authorised it on 25 October 2017.
Who is the marketing authorisation holder for Varubi in United States?
TESARO INC holds the US marketing authorisation.