FDA Expands Cumberland’s Caldolor Labeling to Include Infants

The FDA has approved expanded labeling of Cumberland Pharmaceuticals’ Caldolor to include use in infants three months to six months of age, for the treatment of fever and pain.

Caldolor was previously approved for pre-operative administration for adults and children six months and older as a non-narcotic pain reliver that enables patients to wake up from their procedures experiencing less pain.

The drug is the only non-opioid product delivered through injection approved to treat pain in infants, the company said.

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