FDA — authorised 16 April 2021
- Application: BLA761111
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
FDA authorised Neulasta on 16 April 2021
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 16 April 2021.
HOSPIRA INC holds the US marketing authorisation.