Teva, Eagle Pharmaceuticals Score FDA Approval for Leukemia Candidate

Teva Pharmaceutical Industries and Eagle Pharmaceuticals have scored FDA approval for Bendeka (bendamustine hydrochloride) injection for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The drug was previously granted orphan drug designation for both indications. Teva will be responsible for all U.S. commercial activities for the product, which is expected to be launched in the first quarter of 2016.