Prescription medicine

Rusfertide Brand names: Mimrylo

Rusfertide (Mimrylo) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the rusfertide FDA label on DailyMed (effective August 28, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 220605 record on Drugs@FDA; every rusfertide label on DailyMed.

Highlights of the record

FDA label of August 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).

Forms and strengths

Kit.

On the market

Earliest approval on file: August 28, 2026 Mimrylo, Takeda Pharms Am; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is rusfertide used for?

From the label: indications and usage
MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).

Source: FDA drug label (MIMRYLO), Takeda Pharmaceuticals America, Inc., effective August 28, 2026 (SPL set 101aff01-31ed-4841-a8b6-0a5a8503189b), via openFDA; the full label on DailyMed

Is there a generic for rusfertide (Mimrylo)?

No generic rusfertide is approved (Drugs@FDA, October 8, 2026).

2026 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Check an interaction: what two or more labels say about each other