BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Labeling Feedback for Preservative-Free Ketamine Application
NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a letter from the FDA Office of Generic Drugs indicating only minor formatting comments on the proposed label for its preservative-free ketamine product, with a final label submission expected this month and potential approval of its Abbreviated New Drug Application anticipated in Summer 2026 pending final review. The company noted the product could help expand U.S. ketamine supply amid reported shortages and aligns with federal efforts to re-shore critical drug manufacturing, while NRx also continues advancing a Fast Track-designated New Drug Application to evaluate intravenous ketamine for severe depression with suicidal ideation. To…











