---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-018467"
form_type: "8-K"
ticker: "CPIX"
cik: "0001087294"
company_name: "CUMBERLAND PHARMACEUTICALS INC"
filed_at: "2023-05-16T23:59:59+00:00"
generated_at: "2026-06-14T23:11:31.204427+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-23-018467
- form_type: 8-K
- ticker: CPIX
- cik: 0001087294
- company_name: CUMBERLAND PHARMACEUTICALS INC
- filed_at: 2023-05-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1087294/000162828023018467/0001628280-23-018467-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1087294/000162828023018467/cpix-20230516.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-018467
- JSON: https://secwatch.observer/filing/0001628280-23-018467.json
- Plain text: https://secwatch.observer/filing/0001628280-23-018467.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.