FDA Regulated SDC-Based Product Development
PURE's SDC technology also shows promise as a broad-spectrum antimicrobial and anti-fungal for use in human and veterinary healthcare products. PURE has initially chosen to pursue approvals through the U.S. Food and Drug Administration (FDA) by partnering with Therapeutics, Incorporated, which has assumed responsibility for funding and managing the testing and regulatory process for selected potential FDA regulated SDC-based products. Therapeutics, Incorporated is focusing on development of the following SDC-based products for the treatment of bacterial, viral and fungal mediated diseases and conditions:
- Hand Sanitizer
- Athlete's Foot
- Nail Fungus
- Vaginal Anti-Infectives
- Acne
Therapeutics, Incorporated expects its development work will result in multiple Investigational New Drug (IND) filings with the US FDA.