The United States 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) for the treatment of Indolent B-cell non-Hodgkin lymphoma (NHL).
"Tentative approval" means that FDA has concluded 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. The tentative approval will convert to a final approval subject to the resolution of the current patent litigation on-going between Eagle and Teva Pharmaceutical Industries Ltd. (Teva), and the resolution or expiry of certain Orphan Drug exclusivities held by Teva.
“We are pleased to have achieved this critical milestone for our improved bendamustine RTD formulation, which we believe will benefit patients and healthcare providers alike,” stated Scott Tarriff, president and chief executive officer. “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.”
The currently marketed bendamustine HCI product is a lyophilized powder requiring 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.
Eagle is currently engaged in litigation defending a patent claim filed by Teva regarding our tentatively approved NDA. The US Patent and Trademark Office has issued patent 8,609,707 for Eagle’s unique formulation of bendamustine hydrochloride injection.
Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing injectable products utilizing the FDA's 505(b)(2) regulatory pathway.