---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-034284"
form_type: "8-K"
ticker: "NRXP"
cik: "0001719406"
company_name: "NRX Pharmaceuticals, Inc."
filed_at: "2026-11-02T13:06:07+00:00"
generated_at: "2026-11-02T13:10:15.710375+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# NRx Pharma wins FDA approval of preservative-free ketamine ANDA, ahead of Nov 10 GDUFA goal date

## Summary
- FDA approved NRx's ANDA for Preservative-Free Ketamine ahead of the Nov 10, 2026 GDUFA goal date; CEO Javitt says commercial supply is on hand for labeling now.
- Product is U.S.-manufactured with Nephron Pharmaceuticals in West Columbia, South Carolina, using blow-fill-seal technology and contains no benzethonium chloride (BZT).
- NRx says all currently marketed ketamine injections contain BZT, which FDA has declined to designate GRAS; NRx filed a Citizen Petition seeking BZT's removal from ketamine.
- Ketamine injection has been in short supply since 2018 and is on FDA's shortage list, with some manufacturers discontinuing production, per the release.
- No pricing, financial terms, or revenue guidance were disclosed; company hosted a call at 8:30 a.m. ET on October 30, 2026.

## SEC filing metadata
- accession: 0001437749-26-034284
- form_type: 8-K
- ticker: NRXP
- cik: 0001719406
- company_name: NRX Pharmaceuticals, Inc.
- filed_at: 2026-11-02T13:06:07+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1719406/000143774926034284/0001437749-26-034284-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1719406/000143774926034284/nrxp20261030_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-034284
- JSON: https://secwatch.observer/filing/0001437749-26-034284.json
- Plain text: https://secwatch.observer/filing/0001437749-26-034284.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.