FDA Approves BENDEKA (bendamustine hydrochloride) Injection

Teva Pharmaceutical Industries Ltd and Eagle Pharmaceuticals, Inc announced that the US Food and has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) as well as the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

BENDEKA is contraindicated in patients with a known hypersensitivity to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

The mot common adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue.

BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.

Teva, who is responsible for all US commercial activities for the product including promotion and distribution, expects BENDEKA to be commercially available to prescribers during the first quarter of 2016.

For prescribing information, visit www.bendeka.com/PrescribingInformation.PDF.