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FDA Approves NRx Pharma's Preservative-Free Ketamine Breakthrough

FDA approves NRx Pharmaceuticals' preservative-free ketamine petition, enabling ANDA re-filing for KETAFREE™. Breakthrough addresses toxic preservative concerns in $750M market.

This development matters because it addresses critical safety concerns in mental health treatment while potentially improving patient outcomes. Current ketamine formulations contain Benzethonium Chloride, a known toxic preservative that can cause tissue damage and adverse reactions. By eliminating this additive through single-patient dosing, NRx's approach could reduce treatment complications and make ketamine therapy safer for patients suffering from depression, PTSD, and other conditions. Given the growing mental health crisis and ketamine's proven efficacy for treatment-resistant depression, this innovation could expand safe access to a vital therapeutic option while setting new standards for pharmaceutical manufacturing safety.