For primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. NDA 215842, held by Novo. Nedosiran Sodium.
As of Nov 13, 2026, NDA 215842 (Rivfloza), held by Novo, was first approved by FDA on Sep 29, 2023, with 1 approved supplement and 0 published complete response letters.
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 )].
| Mar 27, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| RivflozaEQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) · solution;injection | Nedosiran Sodium | RxReference drug |
| RivflozaEQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) · solution;injection | Nedosiran Sodium | RxReference drug |
| RivflozaEQ 160MG BASE/ML (EQ 160MG BASE/ML) · solution;injection | Nedosiran Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
