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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

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

Further information

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