FDA — authorised 23 January 2015
- Application: BLA125511
- Marketing authorisation holder: NPS PHARMS INC
- Status: supplemented
FDA authorised Hormone on 23 January 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 23 January 2015; FDA has authorised it.
NPS PHARMS INC holds the US marketing authorisation.