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ADVENTRX Pharmaceuticals Receives PDUFA Date for Exelbine™ NDA
Date:1/19/2011

cals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.  More information can be found on the Company's web site at www.adventrx.com.    

Forward Looking Statements

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the timing and receipt of regulatory approval of Exelbine based on the 505(b)(2) NDA accepted for filing, working with the FDA in the regulatory review process and the bioequivalence of Exelbine and Navelbine. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that ADVENTRX does not receive FDA approval of Exelbine on a timely basis, or at all; the potential for the FDA to determine that the bioequivalence data and other information included in the Exelbine NDA does not adequately support bioequivalence with Navelbine, including as a result of performing pharmacokinetic equivalence analyses based on a patient population other than the population on which ADVENTRX based its analysis; the potential that changes made in transferring the manufacturing process for Exelbine may result in a lack of comparability between the commercial product and the material used in the bioequivalence trial; the risk that results of future stability testing on samples of Exelbine do not support comparability between ADVENTRX's prior and intended commercial manufacturing sites or a commercially-viable expiration dating period; the po
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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