Treats Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle … without papillary tumors. NDA 219683, held by Janssen Biotech. Gemcitabine Hydrochloride.
As of Nov 13, 2026, NDA 219683 (Inlexzo), held by Janssen Biotech, was first approved by FDA on Sep 9, 2025, with 0 approved supplements and 0 published complete response letters.
INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2025 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| InlexzoEQ 225MG BASE · system;intravesical | Gemcitabine Hydrochloride | 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
