The expanded labeling allows for an intravenously delivered formulation of ibuprofen (Caldolor) in infants aged 3 to 6 months.
The FDA has approved expanded labeling for an intravenously delivered formulation of ibuprofen (Caldolor; Cumberland Pharmaceuticals) to treat fever and pain in infants aged 3 months to 6 months, according to a recent press release from Cumberland Pharmaceuticals.1
With the label expansion, ibuprofen is now approved for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain as a monotherapy, and for the management of moderate to severe pain as an adjunct to an opioid. According to Cumberland Pharmaceuticals, ibuprofen is the only non-opioid product FDA-approved to treat pain in infants that is delivered through injection.
The FDA-approved label includes the product’s indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in the pediatric patient population.
The expanded label approval follows the established safety and efficacy of ibuprofen to treat pain and fever in patients 3 months and up, demonstrated from 1 adequate and controlled open-label study in infants. Additionally, “Safety data from  studies in 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and evidence from adequate and well-controlled studies in adults,” has further established safety and efficacy according to Cumberland Pharmaceuticals.