Biomednewsbreaks - Nrx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Feedback On Bioequivalence For Ketamine Product

(MENAFN- Investor Brand Network) NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a letter from the FDA's Bioequivalence Program stating no bioequivalence deficiencies were identified at this time in its Abbreviated New Drug Application, with a preliminary determination ahead of anticipated approval in Summer 2026. The company highlighted its preservative-free ketamine formulation, which excludes benzethonium chloride, as a potential advancement in safety and stability, while continuing to pursue regulatory pathways for broader therapeutic use.

To view the full press release, visit

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (), 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

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