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FDA approves NRx Pharmaceuticals' preservative-free ketamine ANDA ahead of November goal date
NRXPNRX Pharmaceuticals, Inc.
The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application for Preservative-Free Ketamine, an American-manufactured presentation that excludes benzethonium chloride, a toxic antimicrobial preservative. The approval was granted ahead of the November 10, 2026 GDUFA goal date. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders including depression and PTSD.