gemcitabine intravesical

FDA Drug Profile — INLEXZO

gemcitabine intravesical is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including INLEXZO. Available dosage form: system.

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 )