NRX Pharmaceuticals Receives Critical FDA Clearance for Ketamine Product

NRX Pharmaceuticals shares are positioned for a potentially transformative period following a pivotal regulatory development. The U.S. Food and Drug Administration has granted approval for a Suitability Petition concerning KETAFREE, the company’s preservative-free ketamine formulation. This regulatory milestone enables the immediate resubmission of an Abbreviated New Drug Application, creating a direct pathway toward commercial availability.

This FDA authorization represents a fundamental shift for NRX Pharmaceuticals’ commercial strategy. The clearance facilitates the transition from multi-dose packaging containing preservatives to single-dose, preservative-free presentations. Company leadership emphasizes the dual significance of this advancement: supporting domestic pharmaceutical manufacturing initiatives while eliminating potentially harmful additives... Read more...