Bendeka FDA Approval History
FDA Approved: Yes (First approved December 7, 2015)
Brand name: Bendeka
Generic name: bendamustine hydrochloride
Dosage form: Injection
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
Bendeka (bendamustine hydrochloride) is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Bendeka is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine.Development timeline for Bendeka
Date | Article |
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Dec 8, 2015 | Approval Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of Bendeka (bendamustine hydrochloride) Injection |
Further information
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