BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Labeling Feedback for Preservative-Free Ketamine Application

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a letter from the FDA Office of Generic Drugs indicating only minor formatting comments on the proposed label for its preservative-free ketamine product, with a final label submission expected this month and potential approval of its Abbreviated New Drug Application anticipated in Summer 2026 pending final review. The company noted the product could help expand U.S. ketamine supply amid reported shortages and aligns with federal efforts to re-shore critical drug manufacturing, while NRx also continues advancing a Fast Track-designated New Drug Application to evaluate intravenous ketamine for severe depression with suicidal ideation.

To view the full press release, visit https://ibn.fm/dIv62

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP

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