ADVENTRX Pharmaceuticals, Inc. (ANX) said it has submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration for its product candidate ANX-530.
ANX-530 is ADVENTRX's proprietary emulsion formulation of vinorelbine.
The company is seeking approval of ANX-530 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, which relies in part on the FDA's findings of safety and effectiveness of a reference drug. The company's 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of ANX 530 and Navelbine, the reference drug.
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