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NRx Pharma's KETAFREE Gets FDA Review Date, Targets Safer Ketamine

NRx Pharmaceuticals announces FDA receipt of ANDA for KETAFREE, a preservative-free ketamine with July 2026 review date, targeting safer alternatives for depression and pain.

This development matters because it addresses a critical safety issue in ketamine therapy, which is increasingly used for depression and pain. Current multidose vials contain Benzethonium Chloride, a preservative the FDA no longer deems safe, posing risks to patients. KETAFREE offers a preservative-free, single-patient alternative, potentially reducing adverse effects and improving treatment outcomes. For individuals relying on ketamine for severe conditions like suicidal depression or chronic pain, this could mean safer, more effective care. From a broader perspective, it aligns with public health initiatives to eliminate toxic substances from medications and strengthens domestic pharmaceutical supply chains, enhancing drug security. If approved, it may accelerate access to innovative therapies, setting a new standard for drug formulation safety in mental health treatment.