FDA — authorised 16 August 2019
- Marketing authorisation holder: IMPACT
- Status: approved
🇺🇸 Inrebic in United States
FDA authorised Inrebic on 16 August 2019
Marketing authorisations
FDA — authorised 23 November 2021
- Application: NDA212327
- Marketing authorisation holder: BRISTOL-MYERS
- Indication: Labeling
- Status: approved
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 16 August 2019; FDA authorised it on 23 November 2021.
Who is the marketing authorisation holder for Inrebic in United States?
IMPACT holds the US marketing authorisation.