FDA — authorised 13 March 2003
- Marketing authorisation holder: ROCHE
- Status: approved
🇺🇸 Fuzeon in United States
FDA authorised Fuzeon on 13 March 2003
Marketing authorisations
FDA — authorised 13 March 2003
- Application: NDA021481
- Marketing authorisation holder: ROCHE
- Local brand name: FUZEON
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
Fuzeon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Fuzeon approved in United States?
Yes. FDA authorised it on 13 March 2003; FDA authorised it on 13 March 2003.
Who is the marketing authorisation holder for Fuzeon in United States?
ROCHE holds the US marketing authorisation.