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Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM)
Date:6/11/2009

New drug is first injectable product approved for sale in the United Statesfor treatment of pain and fever

NASHVILLE, Tenn., June 11 /PRNewswire/ -- Cumberland Pharmaceuticals (www.cumberlandpharma.com) today announced the U.S. Food and Drug Administration (FDA) has approved Caldolor(TM), an intravenous formulation of ibuprofen, through a priority review. Caldolor is the first and only injectable product approved for sale in the United States for the treatment of both pain and fever.

Caldolor will be used primarily in hospitalized patients who are unable to receive oral therapies for pain relief and fever reduction. The only injectable drugs currently available to reduce pain are opioids, such as morphine and meperdine, and ketorolac, a non-steroidal anti-inflammatory drug. Opioids can cause sedation, nausea, vomiting, cognitive impairment, and respiratory depression. Ketorolac is associated with an increased risk of bleeding as well as gastrointestinal and renal complications. Despite these side effects, the U.S. market for injectable pain relievers was approximately 679 million units in 2008. Currently, there is no FDA approved intravenous therapy for reduction of fever other than Caldolor.

"The approval of Caldolor gives physicians, long comfortable with the use of oral ibuprofen formulations, an alternative therapy for pain and fever in the hospital setting where an injectable medicine is often needed," said Ken Holroyd, Assistant Vice Chancellor for Research and Associate Professor of Anesthesiology & Medicine at Vanderbilt University. "An FDA approved injectable fever therapy, and an alternative to injectable narcotic pain therapy, is welcomed."

Clinical trials have shown Caldolor to be safe and effective in reducing both pain and fever in 1,400 hospitalized patients. In Phase III studies,
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SOURCE Cumberland Pharmaceuticals
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