FDA — authorised 1 June 1989
- Marketing authorisation holder: AMGEN
- Status: approved
🇺🇸 Epogen in United States
FDA authorised Epogen on 1 June 1989
Marketing authorisations
FDA — authorised 24 June 2011
- Application: BLA103234
- Marketing authorisation holder: AMGEN
- Indication: Labeling
- Status: approved
FDA — authorised 15 May 2018
- Application: BLA125545
- Marketing authorisation holder: HOSPIRA INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
Epogen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Epogen approved in United States?
Yes. FDA authorised it on 1 June 1989; FDA authorised it on 24 June 2011; FDA authorised it on 15 May 2018.
Who is the marketing authorisation holder for Epogen in United States?
AMGEN holds the US marketing authorisation.