nelarabine

FDA Drug Profile — NELARABINE, nelarabine, Arranon

Drug Details

Generic Name
nelarabine
Brand Names
NELARABINE, nelarabine, Arranon
Application Number
ANDA218554
Sponsor
Alembic Pharmaceuticals Inc.
NDC Codes
7
Dosage Forms
INJECTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
NELARABINE

Indications and Usage

1 INDICATIONS AND USAGE Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )