Teva, Eagle Pharma Report FDA Approval Of BENDEKA Injection

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) and Eagle Pharmaceuticals, Inc. (EGRX) Tuesday said the U.S. Food and Drug Administration has approved BENDEKA, (bendamustine hydrochloride) injection, a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine.

BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia or CLL and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma or NHL that has progressed during or within six 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 was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.

Under the February 2015 exclusive license agreement for BENDEKA, Teva is responsible for all U.S. commercial activities for the product including promotion and distribution.

Teva expects to make BENDEKA commercially available to prescribers during the first quarter of 2016.