# BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives Positive FDA Review Letter Supporting Ketamine ANDA Progress

- URL: https://theranews.net/blog/2026-04-23-biomednewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-positive-fda-revie-22caf4/
- Published: 2026-04-23
- Type: Archive summary (AI-assisted summary of third-party reporting)
- Original outlet: financialcontent
- Original report: https://www.financialcontent.com/article/nnwire-2026-4-22-biomednewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-positive-fda-review-letter-supporting-ketamine-anda-progress
- Topics: depression
- Publisher: TheraNews, operated by AdvancedCare USA Inc.
- Notice: Educational content, not medical, legal, billing or financial advice. Cite the original outlet, not this summary.

> NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a positive Discipline Review Letter from the FDA Office of Generic Drugs covering quality-related aspects of its ketamine ANDA, with only minor administrative updates requested. The company also reported a supportive meeting with FDA leadershi

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NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a positive Discipline Review Letter from the FDA Office of Generic Drugs addressing quality-related aspects of its ketamine ANDA (Abbreviated New Drug Application), with only minor administrative updates requested. The company also reported a supportive meeting with FDA leadership aligned with federal priorities to accelerate treatments for severe mental illness.

The company expects potential approval of its preservative-free ketamine product in summer 2026. NRx-100 (preservative-free intravenous ketamine) has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. The company has also filed a New Drug Application with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. In addition to NRX-100, the company is developing NRX-101 (oral D-cycloserine/lurasidone), which has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx maintains an extensive research portfolio of investigational novel serotonergic agonists.

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*This article is an AI-assisted summary. All facts and figures are drawn from the original report: [https://www.financialcontent.com/article/nnwire-2026-4-22-biomednewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-positive-fda-review-letter-supporting-ketamine-anda-progress](https://www.financialcontent.com/article/nnwire-2026-4-22-biomednewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-positive-fda-review-letter-supporting-ketamine-anda-progress)*