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Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance(TM) for Treatment of Acute Pain and Fever
Date:7/15/2009

istorical facts are forward-looking statements that are based on Cadence's current beliefs and expectations. Forward-looking statements include statements regarding the anticipated action date for the FDA to complete its review of the Acetavance NDA and the company's belief that this product candidate may fulfill an unmet medical need for a new class of intravenous medication to treat acute pain and fever in adults and children. The inclusion of forward-looking statements such as these should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the company's business, including, without limitation: the possibility that the clinical trial and other data and information included in the NDA for Acetavance may be insufficient to support FDA approval or that adverse side effects associated with this product candidate may be more prevalent or severe than anticipated, which could prevent or significantly delay its regulatory approval; the potential that the FDA may require Cadence to perform additional studies, tests or other activities, or request additional information or clarification regarding information already provided, which could substantially delay the approval of the NDA; the possibility that the FDA's evaluations of the NDA or the company's clinical and manufacturing procedures and facilities may raise issues that must be resolved prior to obtaining final approval of the NDA; the risk that heightened scrutiny by the FDA over the new drug approval process and concerns regarding accidental and intentional overdoses of acetaminophen, primarily in the outpatient setting, may delay or prevent the approval of Acetavance, limit the indications for use or otherwise adversely impact the approved labeling for this product candidate; intense competition from existing and new products, which could diminish the com
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SOURCE Cadence Pharmaceuticals, Inc.
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