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NRx Pharmaceuticals Reports FDA Reclassifies Ketamine Amendment As Minor

Source: Nasdaq

Healthcare & BiotechRegulation & LegislationProduct Launches

NRx Pharmaceuticals said the FDA reclassified an amendment to its ANDA for NRX-100, a preservative-free intravenous ketamine formulation. The regulatory reclassification is a constructive development for the clinical-stage biotech's path toward potential approval and commercialization, though the article excerpt does not provide a revised review timeline or approval decision.

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