FDA — authorised 12 October 2007
- Marketing authorisation holder: SHIONOGI INC
- Status: approved
FDA authorised Doribax on 12 October 2007
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 October 2007; FDA authorised it on 12 October 2007.
SHIONOGI INC holds the US marketing authorisation.