Bendamustine

FDA Drug Profile

Bendamustine is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: powder.

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 Bendamustine hydrochloride for 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) Bendamustine hydrochloride for injection 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) Bendamustine hydrochloride for injection 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 regime n.