Treats moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP). Sold as Korsuva. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Difelikefalin Acetate (sold as Korsuva), first approved Aug 23, 2021, with 0 new uses approved and 0 published complete response letters.
| Aug 23, 2021 | KorsuvaNDA 214916 · New molecular entity | Vifor Intl | 1 | Marketed |
| Aug 31, 2026 | Difelikefalin AcetateANDA 220919 | Qilu Pharm Hainan | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
