FDA — authorised 20 December 2019
- Application: BLA761062
- Marketing authorisation holder: AMGEN INC
- Indication: Labeling
- Status: approved
FDA authorised EVENITY on 20 December 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 20 December 2019.
AMGEN INC holds the US marketing authorisation.