---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-021318"
form_type: "8-K"
ticker: "CPIX"
cik: "0001087294"
company_name: "CUMBERLAND PHARMACEUTICALS INC"
filed_at: "2023-06-07T23:59:59+00:00"
generated_at: "2026-06-14T05:37:24.037458+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Cumberland Pharmaceuticals receives FDA waiver, $1.2M refund for RediTrex fees

## Summary
- FDA granted barrier-to-innovation waiver based on ifetroban clinical programs addressing unmet medical needs.
- Company will receive refund of approximately $1.2 million in prescription drug program fees for RediTrex.
- Refund expected within 45 days from FDA's Office of Financial Management.
- Waiver follows Cumberland's April 3, 2023 request for reconsideration through counsel.

## SEC filing metadata
- accession: 0001628280-23-021318
- form_type: 8-K
- ticker: CPIX
- cik: 0001087294
- company_name: CUMBERLAND PHARMACEUTICALS INC
- filed_at: 2023-06-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1087294/000162828023021318/0001628280-23-021318-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1087294/000162828023021318/cpix-20230602.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-021318
- JSON: https://secwatch.observer/filing/0001628280-23-021318.json
- Plain text: https://secwatch.observer/filing/0001628280-23-021318.txt

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