FDA — authorised 25 April 1957
- Application: NDA010787
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: IRON DEXTRAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Imferon in United States
FDA authorised Imferon on 25 April 1957
Marketing authorisations
FDA — authorised 26 March 1981
- Application: NDA017807
- Marketing authorisation holder: NEW RIVER
- Local brand name: PROFERDEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 1996
- Application: NDA040024
- Marketing authorisation holder: AM REGENT
- Local brand name: DEXFERRUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Imferon 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 Imferon approved in United States?
Yes. FDA authorised it on 25 April 1957; FDA authorised it on 26 March 1981; FDA authorised it on 23 February 1996.
Who is the marketing authorisation holder for Imferon in United States?
SANOFI AVENTIS US holds the US marketing authorisation.