Adventrx Pharmaceuticals Inc. (ANX) said that the U.S. FDA has set September 1, 2011 as the Prescription Drug User Fee Act date for the company's Exelbine or ANX-530 new drug application.
The company is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. The company 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.
The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by Adventrx to be bioequivalent.
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