Treats moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP). NDA 214916, held by Vifor Intl. Difelikefalin Acetate.
As of Nov 13, 2026, NDA 214916 (Korsuva), held by Vifor Intl, was first approved by FDA on Aug 23, 2021, with 1 approved supplement and 0 published complete response letters.
KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| KorsuvaEQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) · solution;intravenous | Difelikefalin Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 25, 2025 | Supplement 2Manufacturing · Standard review | Approved | |
| Aug 23, 2021 | Original applicationNew molecular entity · Priority review | Approved |
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
