regulatory
confidence high
sentiment positive
materiality 0.55
FDA reminds providers PEDMARK is not substitutable with other STS products
FENNEC PHARMACEUTICALS INC.
- 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.