Product Safety And DifferentiationKETAFREE's preservative-free formulation provides a safety differentiation versus preservative-containing ketamine products, which could encourage adoption by clinics seeking a cleaner labeled option.
Real-world EvidenceA very large real-world dataset on intravenous ketamine outcomes strengthens the supporting evidence and can bolster regulatory discussions and clinician confidence in ketamine-based treatments.
Regulatory ProgressFDA acceptance of the ANDA for KETAFREE and characterization of the filing as substantially complete reduce regulatory uncertainty and create a clearer path toward commercial launch.