For primary immunoglobulin A nephropathy (IgAN). NDA 215935, held by Calliditas. Budesonide.
As of Nov 13, 2026, NDA 215935 (Tarpeyo), held by Calliditas, was first approved by FDA on Dec 15, 2021, with 3 approved supplements and 0 published complete response letters.
TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2023 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2021 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tarpeyo4MG · capsule, delayed release;oral | Budesonide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 5, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Dec 20, 2023 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2021 | Original applicationNew formulation or manufacturer · 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
