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NRX Pharmaceuticals Seeks FDA's Priority Review for Preservative-Free IV Ketamine
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NRX Pharmaceuticals Seeks FDA's Priority Review for Preservative-Free IV Ketamine
Jun 5, 2025 5:58 AM

08:40 AM EDT, 06/05/2025 (MT Newswires) -- NRX Pharmaceuticals ( NRXP ) said Thursday it is seeking priority review from the US Food and Drug Administration for its preservative-free intravenous ketamine formulation NRX-100 based on current and expected drug shortage.

The company said it filed its abbreviated new drug application for NRX-100 for use in all existing approved indications, including anesthesia and pain management.

NRX Pharmaceuticals ( NRXP ) said it expects filing a citizen's petition with the FDA to remove benzethonium chloride from all presentations of ketamine intended for intravenous use.

The company said its management believes that NRX-100's preservative-free feature will benefit patients due to the known toxicity of closely related benzalkonium chloride in existing drug products.

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