FDA — authorised 19 December 2025
- Application: BLA761456
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Local brand name: BONCRESA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 BONCRESA in United States
FDA authorised BONCRESA on 19 December 2025
Marketing authorisations
FDA — authorised 19 December 2025
- Application: BLA761457
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Local brand name: OZILTUS
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
BONCRESA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is BONCRESA approved in United States?
Yes. FDA authorised it on 19 December 2025; FDA authorised it on 19 December 2025.
Who is the marketing authorisation holder for BONCRESA in United States?
AMNEAL PHARMS LLC holds the US marketing authorisation.