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Bendeka 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 History and FDA Approval Process for Bendeka

DateArticle
Dec  8, 2015Approval Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of Bendeka (bendamustine hydrochloride) Injection

Further information

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