FDA — authorised 26 November 2018
- Marketing authorisation holder: LOXO ONCOLOGY INC
- Status: approved
🇺🇸 Vitrakvi in United States
FDA authorised Vitrakvi on 26 November 2018
Marketing authorisations
FDA — authorised 26 November 2018
- Application: NDA211710
- Marketing authorisation holder: BAYER HEALTHCARE
- Local brand name: VITRAKVI
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 November 2018
- Application: NDA210861
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: VITRAKVI
- Indication: CAPSULE — ORAL
- Status: approved
Vitrakvi 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 Vitrakvi approved in United States?
Yes. FDA authorised it on 26 November 2018; FDA authorised it on 26 November 2018; FDA authorised it on 26 November 2018.
Who is the marketing authorisation holder for Vitrakvi in United States?
LOXO ONCOLOGY INC holds the US marketing authorisation.