FDA — authorised 7 July 2008
- Application: BLA125164
- Marketing authorisation holder: HOFFMAN-LA ROCHE
- Indication: Labeling
- Status: approved
🇺🇸 epoetin in United States
FDA authorised epoetin on 7 July 2008
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
epoetin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is epoetin approved in United States?
Yes. FDA authorised it on 7 July 2008; FDA authorised it on 24 June 2011; FDA authorised it on 15 May 2018.
Who is the marketing authorisation holder for epoetin in United States?
HOFFMAN-LA ROCHE holds the US marketing authorisation.