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Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
Date:11/13/2009

etting. The company is currently developing IV acetaminophen, an investigational product candidate for the treatment of acute pain and fever. For more information about Cadence, please visit www.cadencepharm.com.

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "expects," "anticipates," "planning," "will," and "potential," and similar expressions, are intended to identify forward-looking statements, and are based on Cadence's current beliefs and expectations. Forward-looking statements include statements regarding: the potential that the FDA will approve Cadence's NDA for IV acetaminophen by the extended PDUFA goal date; the company's plans to accelerate the development of its commercial and supply operations infrastructure; and the timing of the launch of IV acetaminophen. 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 FDA may not approve the NDA for IV acetaminophen if the agency determines that the clinical, non-clinical or other data submitted in the NDA are not adequate to support the safety or efficacy of this product candidate, or the agency may require us to conduct additional studies or clinical trials; the possibility that pre-approval inspections by the FDA of the site where IV acetaminophen is manufactured, or Cadence's clinical trial sites, may raise issues that must be resolved prior to obtaining approval of the NDA; the risk that increased attention to drug safety issues may result in a more cautious approach by the FDA, which could d
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SOURCE Cadence Pharmaceuticals, Inc.
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