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

hen is approved in approximately 80 countries, including major markets in Europe, where it is the market leader among all injectable analgesics. Approximately 90 million vials of IV acetaminophen were sold in Europe in 2008 representing an increase of approximately 13% over 2007.

The NDA for IV acetaminophen includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of fever. The NDA is further supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received IV acetaminophen in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to IV acetaminophen in countries outside the United States.

Conference Call and Webcast on November 13, 2009 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time)

Cadence management will host a conference call on November 13, 2009 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time) and interested investors may participate in the conference call by dialing 800-967-7137 (domestic) or 719-785-9446 (international). To access the webcast, please visit the company's website at www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call and remain available on the company's website until the next quarterly financial results call.

About Cadence

Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital s
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SOURCE Cadence Pharmaceuticals, Inc.
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