# Psychedelicnewsbreaks Nrx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Labeling Feedback For Preservative-Free Ketamine Application

- URL: https://theranews.net/blog/2026-04-07-psychedelicnewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-fda-labeling-32f70c/
- Published: 2026-04-07
- Type: Archive summary (AI-assisted summary of third-party reporting)
- Original outlet: menafn
- Original report: https://menafn.com/1110948178/Psychedelicnewsbreaks-Nrx-Pharmaceuticals-Inc-NASDAQ-NRXP-Receives-FDA-Labeling-Feedback-For-Preservative-Free-Ketamine-Application
- 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 has received a letter from the FDA Office of Generic Drugs indicating only minor formatting comments on the ...

---
NRx Pharmaceuticals, Inc. has received FDA labeling feedback for its preservative-free ketamine application. The clinical-stage biopharmaceutical company is developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD.

NRx is developing NRX-100, a preservative-free intravenous ketamine treatment, and NRX-101, an oral formulation combining D-cycloserine and 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.

The company has filed an Abbreviated New Drug Application 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. The FDA feedback on labeling represents progress in the regulatory pathway for the candidate therapy.

---

*This article is an AI-assisted summary. All facts and figures are drawn from the original report: [https://menafn.com/1110948178/Psychedelicnewsbreaks-Nrx-Pharmaceuticals-Inc-NASDAQ-NRXP-Receives-FDA-Labeling-Feedback-For-Preservative-Free-Ketamine-Application](https://menafn.com/1110948178/Psychedelicnewsbreaks-Nrx-Pharmaceuticals-Inc-NASDAQ-NRXP-Receives-FDA-Labeling-Feedback-For-Preservative-Free-Ketamine-Application)*