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Blog & Resources Camargo Blog June 29th, 2009

ADVENTRX Restarts 505(b)(2) Development

Today June 29, ADVENTRX Pharmaceuticals announced plans to use their recent financing to finish the development of ANX-530 (vinorelbine emulsion) and submit a 505(b)(2) NDA by the end of the year.

Careful readers of this blog may remember a January 2008 posting citing ADVENTRX ANX-530 as an example of where a single pk study might be sufficient for an NDA. The company’s recent press release suggests that there are manufacturing issues needed to complete the filing.

Like many companies, ADVENTRX has had difficulties raising capital to fund its drug development projects. Last month, the company reported disappointing results for its ANX-514 (docetaxel emulsion) product – it failed to meet the usual bioequivalence standards. A 505(b)(2) is not subject to the same statutory goalposts (80 -125% ) as a generic drug but there must be justification for small excursions outside these limits. It is unclear from the press release whether the company had a prior agreement with the Agency to meet these limits.


Categories: 505(b)(2) Development

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