bendamustine hydrochloride
Drug Details
- Generic Name
- bendamustine hydrochloride
- Brand Names
- bendamustine hydrochloride, Bendeka, BENDAMUSTINE HYDROCHLORIDE, BELRAPZO
- 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 & USAGE VIVIMUSTA 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) VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) VIVIMUSTA is indicated for the treatment of adult 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.