Valrubicin Intravesical Solution

FDA Drug Profile — Valrubicin Intravesical Solution

Drug Details

Generic Name
Valrubicin Intravesical Solution
Brand Names
Valrubicin Intravesical Solution
Application Number
ANDA206430
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
1
Dosage Forms
SOLUTION, CONCENTRATE
Routes
INTRAVESICAL
Active Ingredients
VALRUBICIN

Indications and Usage

1 INDICATIONS AND USAGE Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. • Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )