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NRx Pharmaceuticals Announces FDA Receipt Of DISCIPLINE REVIEW LETTER For Changes To Submitted Label For Preservative-Free Ketamine Product Ahead Of Nov. 10

Benzinga·10/15/2026 12:36:08
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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, "NRx" or "the Company"), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the receipt of a "DISCIPLINE REVIEW LETTER" from the US Food and Drug Administration requesting "MINOR" changes to the submitted label for NRx’s Preservative-Free Ketamine product. The letter requests that the Company submits sample labeling with the proposed proprietary product name currently under review in advance of the November 10, 2026, Abbreviated New Drug Application GDUFA goal date.