gemcitabine intravesical
Drug Details
- Generic Name
- gemcitabine intravesical
- Brand Names
- INLEXZO
- Application Number
- NDA219683
- Sponsor
- Janssen Biotech, Inc
- NDC Codes
- 1
- Dosage Forms
- SYSTEM
- Routes
- INTRAVESICAL
- Active Ingredients
- GEMCITABINE
Indications and Usage
1 INDICATIONS AND USAGE 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. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, 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. ( 1 )