bendamustine hydrochloride
Drug Details
- Generic Name
- bendamustine hydrochloride
- Brand Names
- bendamustine hydrochloride, Bendeka, BELRAPZO, BENDAMUSTINE HYDROCHLORIDE
- Application Number
- ANDA205574
- Sponsor
- Accord Healthcare, Inc.
- NDC Codes
- 7
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER, INJECTION, SOLUTION, INJECTION
- Routes
- INTRAVENOUS
- 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.