---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-009551"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2024-02-02T23:59:59+00:00"
generated_at: "2026-06-06T09:45:05.458390+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# FDA reminds providers PEDMARK is not substitutable with other STS products

## Summary
- FDA publicly warned healthcare providers that PEDMARK (sodium thiosulfate injection) must not be substituted with other STS products.
- Substitution risks include potassium chloride exposure (cardiac events) and overexposure to boric acid or sodium nitrite.
- PEDMARK is the only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric solid tumor patients.
- Fennec holds orphan drug exclusivity in the U.S. through 2029 for PEDMARK.
- FDA reminder reinforces PEDMARK's prescribing label and protects product from off-label compounding.

## SEC filing metadata
- accession: 0001104659-24-009551
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2024-02-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465924009551/0001104659-24-009551-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465924009551/tm244893d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-009551
- JSON: https://secwatch.observer/filing/0001104659-24-009551.json
- Plain text: https://secwatch.observer/filing/0001104659-24-009551.txt

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