clofarabine

FDA Drug Profile — CLOFARABINE, clofarabine

Drug Details

Generic Name
clofarabine
Brand Names
CLOFARABINE, clofarabine
Application Number
ANDA204029
Sponsor
Zydus Lifesciences Limited
NDC Codes
3
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
CLOFARABINE

Indications and Usage

1 INDICATIONS AND USAGE Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clofarabine Injection. Clofarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clofarabine Injection. ( 1 )