FDA approves Bendeka from Teva, Eagle Pharmaceuticals

JERUSALEM and WOODCLIFF LAKE, N.J. — Teva Pharmaceuticals and Eagle Pharmaceuticals announced Tuesday that the Food and Drug Administration had approved their Bendeka (bendamustine hydrochloride), an injection and 10-minute infusion formulation. 

 

The drug is indicated to treat patients with chronic lymphocytic leukemia and those with indolent B-cell non-Hodgkin lymphoma that’s progressed during or within six months of being treated with rituximab or a regimen with rituximab. 

 

“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers,” Teva Oncology general manager and SVP Paul Rittman said. “We are pleased to add BENDEKA to Teva’s Oncology portfolio, and bendamustine franchise, furthering our commitment to enhancing treatment options for patients affected by cancer.”

 

Teva said it expects to make Bendeka available in the first quarter of 2016.