secwatch.observer — SEC 8-K summary
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Issuer:     NRX Pharmaceuticals, Inc. (NRXP)
CIK:        0001719406
Form:       8-K
Filed at:   2026-11-02T13:06:07+00:00
Accession:  0001437749-26-034284
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1719406/000143774926034284/0001437749-26-034284-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1719406/000143774926034284/nrxp20261030_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-034284

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