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

patients who were given Caldolor reported a significant reduction in post-surgical pain intensity within the first 24 hours while also significantly reducing their morphine use. Clinical trials including critically ill and non-critically ill patients with fever showed a significant reduction in temperature as compared with those who received a placebo. No serious adverse events were directly attributed to Caldolor in any of these clinical studies.

"We are delighted to obtain FDA approval for the first and only intravenous treatment for pain and fever in the U.S. market," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Cumberland is dedicated to providing innovative products that improve quality of care for patients and address unmet medical needs. We believe Caldolor represents a significant addition to our product portfolio and a substantial market opportunity."

Caldolor is the third drug in Cumberland's portfolio and the second for which Cumberland has completed development and secured FDA approval. The company will promote Caldolor in the United States through its expanded hospital sales force and will use alliances with marketing partners for sales outside of the United States. Caldolor is expected to be available in the U.S. later this year.

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patient
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SOURCE Cumberland Pharmaceuticals
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