---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-010469"
form_type: "8-K"
ticker: "CPIX"
cik: "0001087294"
company_name: "CUMBERLAND PHARMACEUTICALS INC"
filed_at: "2023-04-04T23:59:59+00:00"
generated_at: "2026-06-17T06:15:48.162061+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants barrier-to-innovation waiver; Cumberland to receive ~$1.9M refund for RediTrex fees

## Summary
- FDA reversed prior denial and granted barrier-to-innovation waiver on March 30, 2023, after reconsideration request.
- Refund of approximately $1.9 million in prescription drug program fees for RediTrex expected within 45 days.
- Waiver tied to Cumberland's ifetroban clinical programs addressing unmet medical needs.
- Original $1.9M fee paid Oct 4, 2021; initial denial Nov 1, 2021; reconsideration filed Nov 28, 2021.

## SEC filing metadata
- accession: 0001628280-23-010469
- form_type: 8-K
- ticker: CPIX
- cik: 0001087294
- company_name: CUMBERLAND PHARMACEUTICALS INC
- filed_at: 2023-04-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1087294/000162828023010469/0001628280-23-010469-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1087294/000162828023010469/cpix-20230404.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-010469
- JSON: https://secwatch.observer/filing/0001628280-23-010469.json
- Plain text: https://secwatch.observer/filing/0001628280-23-010469.txt

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