FDA — authorised 25 July 2013
- Marketing authorisation holder: LUITPOLD
- Status: approved
🇺🇸 Injectafer in United States
FDA authorised Injectafer on 25 July 2013
Marketing authorisations
FDA — authorised 16 November 2015
- Application: NDA203565
- Marketing authorisation holder: AM REGENT
- Indication: Manufacturing (CMC)
- Status: approved
Injectafer in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Injectafer approved in United States?
Yes. FDA authorised it on 25 July 2013; FDA authorised it on 16 November 2015.
Who is the marketing authorisation holder for Injectafer in United States?
LUITPOLD holds the US marketing authorisation.