FDA — authorised 15 May 2018
- Application: BLA125545
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: RETACRIT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Epogen on 15 May 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 May 2018; FDA has authorised it.
HOSPIRA INC holds the US marketing authorisation.