Quick answers
- What is Nedosiran used for?
- The FDA-approved label (Rivfloza, Novo Nordisk, March 3, 2025) says: “RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 […], Clinical Studies ( 14.1 )]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nedosiran have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nedosiran?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nedosiran been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nedosiran?
- 1 company lists prescription products of Nedosiran in the FDA NDC Directory, including Novo Nordisk.
What Nedosiran is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 […], Clinical Studies ( 14.1 )]. …
— FDA label: Rivfloza, Novo Nordisk, effective March 3, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Rivfloza |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novo Nordisk3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215842 RIVFLOZA | Novo | September 29, 2023 | 1, latest March 27, 2025 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rivfloza, Novo Nordisk, effective March 3, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →