FDA — authorised 28 October 2020
- Application: NDA212320
- Marketing authorisation holder: SHIELD TX
- Indication: Labeling
- Status: approved
🇺🇸 Accrufer in United States
FDA authorised Accrufer on 28 October 2020
Marketing authorisations
FDA
- Marketing authorisation holder: SHIELD TX
- Status: approved
Accrufer 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 Accrufer approved in United States?
Yes. FDA authorised it on 28 October 2020; FDA has authorised it.
Who is the marketing authorisation holder for Accrufer in United States?
SHIELD TX holds the US marketing authorisation.