FDA — authorised 15 November 2023
- Application: NDA218213
- Marketing authorisation holder: BRISTOL
- Local brand name: AUGTYRO
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Augtyro in United States
FDA authorised Augtyro on 15 November 2023
Marketing authorisations
FDA
- Marketing authorisation holder: BRISTOL
- Status: approved
Augtyro 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 Augtyro approved in United States?
Yes. FDA authorised it on 15 November 2023; FDA has authorised it.
Who is the marketing authorisation holder for Augtyro in United States?
BRISTOL holds the US marketing authorisation.