FDA approved the original new drug application for RIVFLOZA on September 29, 2023, sponsored by NOVO. FDA classed that submission a new molecular entity, which makes it the first approval of nedosiran sodium in any product. FDA has approved 1 efficacy supplement on the application since, the most recent on March 27, 2025.
- Application
- NDA215842
- Sponsor
- NOVO
- Original approval
- Review
- standard review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- nedosiran sodium
Browse every approval whose brand starts with R, 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 |
|---|---|---|---|
| nedosiran sodium EQ 160MG BASE/ML (EQ 160MG BASE/ML) | SOLUTION | INJECTION | Prescription |
| nedosiran sodium EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | SOLUTION | INJECTION | Prescription |
| nedosiran sodium EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) | SOLUTION | INJECTION | 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.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard |
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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