FDA — authorised 25 November 2013
- Application: NDA205098
- Marketing authorisation holder: PROVENSIS
- Local brand name: VARITHENA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA authorised Varithena® on 25 November 2013
Yes. FDA authorised it on 25 November 2013.
PROVENSIS holds the US marketing authorisation.