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FDA approves first injectable ibuprofen

6/12/2009

ROCKVILLE, Md. The Food and Drug Administration has approved the first injectable formulation of the painkiller ibuprofen.

The agency approved Cumberland Pharmaceuticals’ Caldolor for acute pain and fever. At present, the drug is available only for hospital use.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs are promising pain management options,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Drug Products director Bob Rappaport said in a statement. “But until now, there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

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