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news.The US Food and Drug Administration (FDA) has granted tentative approval to Eagle Pharmaceuticals' new drug application (NDA) for patented Bendamustine Hydrochloride Injection, a ready-to-dilute concentrate solution (bendamustine RTD) to treat Indolent B-cell non-Hodgkin lymphoma (NHL).
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The company said that the currently marketed bendamustine HCI product is a lyophilized powder that requires reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for chronic lymphocytic leukemia and 60 minutes for NHL.
The FDA tentative approval means that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the US because of existing patent protections or exclusivities.
Subject to the resolution of the current patent litigation on-going between Eagle and Teva Pharmaceutical, and the resolution or expiry of certain orphan drug exclusivities held by Teva, the tentative approval will be converted to a final approval.
Eagle Pharmaceuticals president and chief executive officer Scott Tarriff said the company is happy to have achieved this critical milestone for its improved bendamustine RTD formulation, which it believes will benefit patients and healthcare providers alike.
"In the interim, we continue to advance our clinical trial of our low-volume, short infusion time bendamustine product, which reduces the diluent volume from 500mL to 50mL and the infusion time to just ten minutes," Tarriff said.
Currently, the company is engaged in litigation defending a patent claim filed by Teva regarding its tentatively approved NDA.