---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-030492"
form_type: "8-K"
ticker: "NRXP"
cik: "0001719406"
company_name: "NRX Pharmaceuticals, Inc."
filed_at: "2026-09-16T01:17:38+00:00"
generated_at: "2026-09-16T10:06:10.742219+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA reclassifies NRx ketamine ANDA amendment from Major to Minor; goal date Nov 10, 2026

## Summary
- FDA Office of Generic Drugs reclassified NRx's preservative-free ketamine ANDA amendment from Major to Minor.
- GDUFA goal date revised to November 10, 2026; FDA cites amendment won't require substantial resource expenditure.
- CEO Jonathan Javitt praised FDA speed in advancing approval of this strategic drug-shortage product.
- Reclassification follows written FDA communication received September 15, 2026.

## SEC filing metadata
- accession: 0001437749-26-030492
- form_type: 8-K
- ticker: NRXP
- cik: 0001719406
- company_name: NRX Pharmaceuticals, Inc.
- filed_at: 2026-09-16T01:17:38+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1719406/000143774926030492/0001437749-26-030492-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1719406/000143774926030492/nrxp20260915_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-030492
- JSON: https://secwatch.observer/filing/0001437749-26-030492.json
- Plain text: https://secwatch.observer/filing/0001437749-26-030492.txt

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