FDA — authorised 10 March 2015
- Marketing authorisation holder: UNITED THERAP
- Status: approved
FDA authorised Ch14.18 on 10 March 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 10 March 2015.
UNITED THERAP holds the US marketing authorisation.