FDA approved the original new drug application for MIMRYLO on August 28, 2026, sponsored by TAKEDA PHARMACEUTICALS U.S.A., INC.. FDA classed that submission a new molecular entity, which makes it the first approval of rusfertide acetate in any product. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA220605
- Sponsor
- TAKEDA PHARMACEUTICALS U.S.A., INC.
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- rusfertide acetate
Browse every approval whose brand starts with M, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| rusfertide acetate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | — | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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