FDA — authorised 12 April 2000
- Marketing authorisation holder: VALEANT LUXEMBOURG
- Status: approved
🇺🇸 Visudyne in United States
FDA authorised Visudyne on 12 April 2000
Marketing authorisations
FDA — authorised 22 August 2001
- Application: NDA021119
- Marketing authorisation holder: BAUSCH LOMB IRELAND
- Indication: Efficacy
- Status: approved
Visudyne in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Visudyne approved in United States?
Yes. FDA authorised it on 12 April 2000; FDA authorised it on 22 August 2001.
Who is the marketing authorisation holder for Visudyne in United States?
VALEANT LUXEMBOURG holds the US marketing authorisation.