FDA — authorised 14 November 2013
- Marketing authorisation holder: MEDICIS
- Status: approved
FDA authorised Luzu on 14 November 2013
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 November 2013; FDA authorised it on 14 November 2013.
MEDICIS holds the US marketing authorisation.