FDA — authorised 28 June 2024
- Application: BLA761126
- Marketing authorisation holder: TANVEX BIOPHARMA USA INC
- Local brand name: NYPOZI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 NYPOZI in United States
FDA authorised NYPOZI on 28 June 2024
Marketing authorisations
FDA
- Status: approved
NYPOZI 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 NYPOZI approved in United States?
Yes. FDA authorised it on 28 June 2024; FDA has authorised it.
Who is the marketing authorisation holder for NYPOZI in United States?
TANVEX BIOPHARMA USA INC holds the US marketing authorisation.