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news.The US Food and Drug Administration (FDA) has accepted for filing Teva Pharmaceutical and Eagle Pharmaceuticals' new drug application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL).
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The agency has issued the Prescription Drug User Fee Act (PDUFA) goal date in December 2015 for a decision on this NDA.
The NDA seeks FDA approval of the rapid infusion bendamustine HCl product to treat CLL and NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The product candidate has received orphan drug designations from the FDA for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity following approval.
The NDA is based on data from a clinical trial completed in November 2014, which showed that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50mL admixture.
Eagle Pharmaceuticals president and chief executive officer Scott Tarriff said: "The rapid infusion bendamustine product, if approved, will be an important new treatment option for patients with CLL or indolent B-cell NHL that has progressed and their healthcare providers.
"We look forward to continuing to work closely with the FDA through the review process, and to their decision on the NDA in December of this year."
In February 2015, Eagle and Teva entered into an exclusive license agreement for the rapid infusion bendamustine product.
Under this deal, Teva will be responsible for all US commercial activities for the product including promotion and distribution, while Eagle will secure all regulatory approvals, conduct post-approval clinical studies, if required, and initially supply drug product to Teva.