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FDA reclassifies NRx Pharmaceuticals' preservative-free ketamine application amendment to Minor, revising GDUFA goal date to November 10, 2026

NRXPNRX Pharmaceuticals, Inc.

NRx Pharmaceuticals announced that the FDA reclassified an amendment to its Abbreviated New Drug Application for preservative-free ketamine from a Major Amendment to a Minor Amendment. This change revised the GDUFA goal date to November 10, 2026, as the minor classification does not require substantial FDA resource expenditure. The company operates in the biopharmaceutical industry.

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