Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals Inc. announce that the U.S. FDA has approved BENDEKA (bendamustine hydrochloride) injection -- a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of 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, according to a press release.
“We are thrilled that the FDA has approved BENDEKA and are excited for what we believe will be a promising launch with Teva. Importantly, we believe that patients with CLL or indolent B-cell NHL that has progressed will benefit from the multiple administration options this product offers,” said Scott Tarriff, president and CEO of Eagle Pharmaceuticals.
“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers,” said Paul Rittman, senior VP and general manager, Teva Oncology.
Teva expects to make BENDEKA commercially available to prescribers during the first quarter of 2016.