FDA approves Caldolor for infants aged 3-6 months; only injectable non-opioid for pain/fever in that age group

CUMBERLAND PHARMACEUTICALS INC

FDA approval expands Caldolor label to include infants 3 months to 6 months for pain and fever.
Caldolor is now the only injectable non-opioid approved for pain treatment in infants.
Approval based on a multi-center study in 21 hospitalized infants; safety and efficacy established from age 3 months.
The company expects Caldolor to be eligible for special Medicare reimbursement under the NOPAIN Act.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.