nedosiran
Drug Details
- Generic Name
- nedosiran
- Brand Names
- RIVFLOZA
- Application Number
- NDA215842
- Sponsor
- Novo Nordisk
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- NEDOSIRAN SODIUM
Indications and Usage
1 INDICATIONS AND USAGE 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 [see Clinical Pharmacology ( 12.3 )], Clinical Studies ( 14.1 )]. RIVFLOZA is an LDHA -directed small interfering RNA 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 . ( 1 )