Treats active lupus nephritis (LN). NDA 213716, held by Aurinia. Voclosporin.
As of Nov 13, 2026, NDA 213716 (Lupkynis), held by Aurinia, was first approved by FDA on Jan 22, 2021, with 2 approved supplements and 0 published complete response letters.
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lupkynis7.9MG · capsule;oral | Voclosporin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Apr 29, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 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
