FDA accepted Teva Pharma’s New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product. The drug, developed with Eagle Pharmaceuticals is now waiting for the Prescription Drug User Fee Act (PDUFA), which is expected for December 2015. In the meantime, the Israeli company remains unstoppable after a great begining of the month on Nasdaq, coinciding with its acquisition of Auspex Pharmaceuticals.
The drug aims the treatment of patients with chronic lymphocytic leukemia (CLL) and 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. This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from a clinical trial completed in November 2014.
Paul Rittman, Vice President and General Manager, Teva Oncology, stated: “We are very pleased the FDA has accepted the rapid infusion bendamustine NDA for review.