Ferabright (ferumoxytol)

New indication (separate NDA)

Region: 🇺🇸 US
Active substance: ferumoxytol
Company: Azurity
Status: Approved
FDA approval: Thu 16 Oct 2025
Designations: New indication (separate NDA)
Application: NDA219868
Official record: www.accessdata.fda.gov

Regulatory milestones

Thu 16 Oct 2025🇺🇸 FDA approval

FDA approves Ferabright (ferumoxytol): new indication (separate nda)

Azurity; NDA219868; New indication (separate NDA); solution · source

Same substance in other markets

🇪🇺 Feraheme Application withdrawn · Covis Pharma Europe B.V.
🇪🇺 Rienso Withdrawn · Takeda Pharma A/S

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.