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news.Adventrx Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine.
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Adventrx retains exclusive worldwide rights to Exelbine, other than in China, Hong Kong, Macau and Taiwan.
Adventrx said that the FDA conditionally accepted Exelbine as the proposed proprietary name for ANX-530, in March 2010.
Adventrx CEO Brian Culley said that their Exelbine submission includes twelve months of site-specific stability data from their intended commercial manufacturer, which fulfills a request communicated to them by the FDA earlier this year.
"We believe this submission will be accepted for review in early 2011 and we look forward to working with the Agency toward our first product approval," Culley said.
Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer.
Adventrx submitted the NDA as a 505(b)(2) application that relies in part on the FDA’s findings of safety and effectiveness of a reference drug.
Adventrx’s 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug.