NDA 214487, held by Chemocentryx. Avacopan.
As of Nov 14, 2026, NDA 214487 (Tavneos), held by Chemocentryx, was first approved by FDA on Oct 7, 2021, with 2 approved supplements and 0 published complete response letters.
TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tavneos10MG · capsule;oral | Avacopan | RxReference drug |
| Jun 3, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Jul 6, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Oct 7, 2021 | Original applicationNew molecular entity · Standard 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
