FDA — authorised 27 November 2013
- Marketing authorisation holder: VIFOR FRESENIUS
- Status: approved
🇺🇸 Ferrlecit in United States
FDA authorised Ferrlecit on 27 November 2013
Marketing authorisations
FDA — authorised 27 August 2024
- Application: NDA205109
- Marketing authorisation holder: VIFOR FRESENIUS
- Indication: Labeling
- Status: approved
The FDA approved Ferrlecit, a product of VIFOR FRESENIUS, for labeling indications on August 27, 2024. This approval was granted through a standard expedited pathway. Ferrlecit's marketing authorization was assigned the application number NDA205109.
Ferrlecit 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 Ferrlecit approved in United States?
Yes. FDA authorised it on 27 November 2013; FDA authorised it on 27 August 2024.
Who is the marketing authorisation holder for Ferrlecit in United States?
VIFOR FRESENIUS holds the US marketing authorisation.