Caldolor now FDA approved for treatment of fever and pain in infants
Cumberland Pharmaceuticals Inc. announced that the FDA has approved expanded labeling for Caldolor an intravenously delivered formulation of ibuprofen, to now include use in infants
The non-narcotic agent may now be administered for the treatment of pain and fever in patients three months to six months of age.
To support this expanded use of Caldolor, Cumberland sponsored a multi-center study in 21 hospitalized infants. All but one patient was treated with a single dose of the product.
The safety and efficacy of Caldolor has now been established for the treatment of pain and fever in pediatric patients aged 3 months and older. Use of Caldolor for these indications is supported by evidence from one adequate and controlled open label study in infants, along with additional safety data from four studies in 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and evidence from adequate and well-controlled studies in adults.
Importantly with this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection. Ketorolac and meloxicam are not approved for use in children, as the safety and efficacy of those drugs have not been established for pediatric patients. Acetaminophen injection is not approved for treating pain in children less than 2 years of age, as the safety and efficacy of that drug has not been established for treating pain in those pediatric patients.
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