Treats recurrent low-grade intermediate-risk non-muscle … bladder cancer (LG-IR-NMIBC). NDA 215793, held by Urogen Pharma. Mitomycin.
As of Nov 15, 2026, NDA 215793 (Zusduri), held by Urogen Pharma, was first approved by FDA on Jun 12, 2025, with 0 approved supplements and 0 published complete response letters.
ZUSDURI is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zusduri40MG/VIAL · powder;intravesical | Mitomycin | RxReference drug |
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
