FDA — authorised 5 November 2009
- Marketing authorisation holder: CELGENE
- Status: approved
FDA authorised Istodax on 5 November 2009
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 5 November 2009.
CELGENE holds the US marketing authorisation.