FDA — authorised 26 August 1998
- Marketing authorisation holder: NOVARTIS
- Status: approved
FDA authorised FOMIVIRSEN on 26 August 1998
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 26 August 1998.
NOVARTIS holds the US marketing authorisation.