NRx Pharmaceuticals Reports Positive FDA Office of Generic Drugs Feedback on Preservative-Free Ketamine Program

NRx Pharmaceuticals received a positive Discipline Review Letter from the FDA Office of Generic Drugs for its preservative-free ketamine program, which requested only minor administrative changes and stability data updates. FDA leadership voiced support for completing the review within the current cycle to address supply shortages, with approval targeted for Summer 2026, aligning with a new Executive Order on mental health treatments.

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