FDA — authorised 4 June 1965
- Marketing authorisation holder: ADVANCE BIOFACTURES
- Status: approved
🇺🇸 Xiaflex in United States
FDA authorised Xiaflex on 4 June 1965
Marketing authorisations
FDA — authorised 4 June 1965
- Application: BLA101995
- Marketing authorisation holder: SMITH AND NEPHEW
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 20 October 2014
- Application: BLA125338
- Marketing authorisation holder: AUXILIUM PHARMS
- Indication: Efficacy
- Status: approved
Xiaflex 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 Xiaflex approved in United States?
Yes. FDA authorised it on 4 June 1965; FDA authorised it on 4 June 1965; FDA authorised it on 20 October 2014.
Who is the marketing authorisation holder for Xiaflex in United States?
ADVANCE BIOFACTURES holds the US marketing authorisation.