FDA — authorised 30 July 2019
- Marketing authorisation holder: BAYER HEALTHCARE PHARMACEUTICALS INC
- Status: approved
🇺🇸 Nubeqa in United States
FDA authorised Nubeqa on 30 July 2019
Marketing authorisations
FDA — authorised 30 July 2019
- Application: NDA212099
- Marketing authorisation holder: BAYER HEALTHCARE
- Local brand name: NUBEQA
- Indication: TABLET — ORAL
- Status: approved
Nubeqa 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 Nubeqa approved in United States?
Yes. FDA authorised it on 30 July 2019; FDA authorised it on 30 July 2019.
Who is the marketing authorisation holder for Nubeqa in United States?
BAYER HEALTHCARE PHARMACEUTICALS INC holds the US marketing authorisation.