U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 220605
Company: TAKEDA PHARMS AM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIMRYLO RUSFERTIDE ACETATE EQ 9.5MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
MIMRYLO RUSFERTIDE ACETATE EQ 19MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
MIMRYLO RUSFERTIDE ACETATE EQ 28MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
MIMRYLO RUSFERTIDE ACETATE EQ 41MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
MIMRYLO RUSFERTIDE ACETATE EQ 54MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/28/2026 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220605Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/28/2026 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf
Back to Top