FDA — authorised 23 November 2021
- Application: NDA212327
- Marketing authorisation holder: BRISTOL-MYERS
- Indication: Labeling
- Status: approved
🇺🇸 Inrebic in United States
FDA authorised Inrebic on 23 November 2021
Marketing authorisation
Inrebic 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 Inrebic approved in United States?
Yes. FDA authorised it on 23 November 2021.
Who is the marketing authorisation holder for Inrebic in United States?
BRISTOL-MYERS holds the US marketing authorisation.