Bendamustine

FDA Drug Profile

Drug Details

Generic Name
Bendamustine
Brand Names
N/A
Application Number
Sponsor
Hetero Labs Limited
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
BENDAMUSTINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.