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Cadence Pharmaceuticals Comments on USPTO's Non-Final, Initial Office Action on Reexamination of Patent
Date:8/15/2013

es the USPTO to consider the scope and validity of the patent based on substantial new questions of patentability raised by a third party or the USPTO.

Cadence intends to continue with the reexamination of all of the rejected claims of the '222 patent and the company is confident in its ability to make a strong case for the patentability of the rejected claims as the process continues.  Additionally, as permitted under USPTO rules, Cadence plans to file additional claims under the '222 patent. From this point forward, third parties are barred from providing additional information in this reexamination.

About OFIRMEV® (Acetaminophen) InjectionOFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA approval of OFIRMEV was based on data from clinical trials in approximately 1,020 adult and 355 pediatric patients. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain, and one study evaluating OFIRMEV in the treatment of fever. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age.

Important Safety InformationDo not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: h
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SOURCE Cadence Pharmaceuticals, Inc.
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