The Food and Drug Administration (FDA) has expanded the approval of Caldolor® (ibuprofen injection) to include infants 3 to 6 months of age for the treatment of pain and fever. Previously, the treatment was approved for patients 6 months of age and older.
Caldolor is now indicated for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. It is also approved for the reduction of fever.
The expanded approval was supported by data from an open-label, non-controlled multicenter study that evaluated the efficacy and safety of Caldolor in 21 hospitalized infants 3 months to less than 6 months of age. Among the 21 patients, 18 were treated with a single dose of Caldolor intravenously.
Use of Caldolor in this patient population was supported by evidence from an open-label and acetaminophen controlled study of fever and additional safety data from 4 studies in 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and evidence from adequate and well-controlled studies in adults.
Caldolor is supplied in ready-to-use premixed bags containing 800mg of ibuprofen in a 200mL low sodium formulation for injection. It is also available in 800mg/8mL single-dose vials that must be diluted before administration.
“We are delighted to provide Caldolor for these youngest of patients,” said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. “We believe that this approval for the product’s use in infants speaks to Caldolor’s favorable safety profile for use in a growing number of patient populations.”
- Caldolor® now FDA approved for treatment of fever & pain in infants. News release. Cumberland Pharmaceuticals Inc. Accessed May 15, 2023. https://www.prnewswire.com/news-releases/caldolor-now-fda-approved-for-treatment-of-fever–pain-in-infants-301823848.html.
- Package insert. Cumberland Pharmaceuticals Inc.; 2023. Accessed May 15, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022348s024lbl.pdf.