Treats low-grade Upper Tract Urothelial Cancer (LG-UTUC). NDA 211728, held by Urogen Pharma. Mitomycin.
As of Nov 14, 2026, NDA 211728 (Jelmyto), held by Urogen Pharma, was first approved by FDA on Apr 15, 2020, with 3 approved supplements and 0 published complete response letters.
JELMYTO is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2020 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jelmyto40MG/VIAL · powder;pyelocalyceal | Mitomycin | RxReference drug |
| Oct 4, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Sep 25, 2022 | Supplement 3Manufacturing | Approved | |
| Jan 14, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Apr 15, 2020 | 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
