Cumberland Pharmaceuticals, a specialty pharmaceutical company, has received the FDA's approval for Caldolor, an intravenous formulation of ibuprofen, through a priority review.
According to Cumberland Pharmaceuticals, Caldolor is the first and only injectable product approved for sale in the US 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 company will promote Caldolor in the US through its expanded hospital sales force and will use alliances with marketing partners for sales outside of the US. Caldolor is expected to be available in the US later in 2009.
A J Kazimi, CEO of Cumberland Pharmaceuticals, said: "We are delighted to obtain FDA approval for the first and only intravenous treatment for pain and fever in the US market. Cumberland is dedicated to providing 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."
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