NRx Pharmaceuticals (Nasdaq:NRXP) Receives FDA Approval of Preservative-Free Ketamine Ahead of November 10 FDA Goal Date

Commercial supply is already manufactured, allowing NRx to proceed with labeling and supply to American hospitals and clinics.

Rhea-AI Summary

NRx Pharmaceuticals (Nasdaq: NRXP) received FDA approval of its generic drug application for preservative-free ketamine ahead of the agency’s goal date.

The approval preceded the November 10 target. The formulation contains no benzethonium chloride, a preservative used in existing ketamine injections. Manufactured commercial supply is on hand; NRx said it can now label the product and supply American hospitals and clinics.

The product is manufactured in the United States with Nephron Pharmaceuticals in West Columbia, South Carolina. NRx aims to address the shortage of traditional glass-bottled ketamine through high-volume “blow-fill-seal” manufacturing technology. The company said ketamine injection has been in short supply since 2018 and currently appears on the FDA drug shortage list.

3 points · 1 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointFDA approval of preservative-free ketamine arrived ahead of the November 10 goal date.
• Minor pointManufactured commercial supply is on hand; NRx said it can now label and supply the product.
• Minor point. Forward-looking: it has not happened yet and may not happen.U.S. manufacturing with Nephron Pharmaceuticals supports NRx’s plan to address ketamine shortages using high-volume blow-fill-seal technology.

Negative

• None.

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+15.75% vs previous close $3.08 last price 712.1x rel. volume Open Argus

Details

Market move: NRXP +15.75% vs previous close. Preservative-free ketamine FDA approval

$2.79 – $3.36 Day Range

$133.31M Mkt Cap at Last Price

On Oct 30, the day this news came out, the latest delayed price for NRXP is 15.75% above the previous close. Our momentum scanner has recorded 10 alerts for this stock so far that day. The latest delayed price is $3.08. Relative volume is exceptionally heavy at 712.1x the average.

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Key Figures

FDA approval goal date: November 10, 2026

FDA approval goal date

November 10, 2026

FDA goal date preceded by the announced approval

Previous Fda approval Reports

1 past event · Latest: Sep 24

Same Type 1 event

1. Sep 24

   FDA petition approval

   24h Move

   +4.9%

   FDA suitability-petition approval enabled ANDA refiling for the same preservative-free ketamine formulation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

abbreviated new drug application (anda), generally recognized as safe (gras), blow-fill-seal, gdufa, +1 more

5 terms

abbreviated new drug application (anda) regulatory

"approved the Company’s Abbreviated New Drug Application (ANDA)"

An Abbreviated New Drug Application (ANDA) is the regulatory request a company files to get approval to market a generic version of an existing prescription drug by showing it has the same active ingredient, strength, dosage form and works the same in the body without repeating full clinical trials. Think of it as proving your copy of a recipe tastes and performs the same as the original. For investors, ANDA approvals determine whether a lower‑cost competitor can enter a market, affecting sales, pricing, patent disputes and the value of both the original drug maker and the generic entrant.

generally recognized as safe (gras) regulatory

"contains no benzethonium chloride (BZT), a toxic antimicrobial preservative that is not Generally Recognized as Safe (GRAS)"

A regulatory designation meaning a substance added to food is considered safe based on a long history of common use or widespread expert agreement, so it does not require the same formal pre-market approval as a new food additive. For investors, GRAS status reduces regulatory risk and speeds time to market—similar to having a fast-pass at a theme park—so products using GRAS ingredients face fewer hurdles, lower costs, and more predictable sales prospects.

blow-fill-seal technical

"through modern, high-volume “blow-fill-seal” technology"

An automated manufacturing process that forms a plastic container, fills it with a sterile liquid or drug, and seals it in one continuous, enclosed operation, reducing exposure to contaminants. Think of it like inflating a balloon, filling it with liquid, and tying it off without ever opening it to the air. For investors, blow-fill-seal matters because it improves product safety and consistency, lowers labor and contamination risk, speeds production, and can reduce regulatory and supply-chain hurdles—factors that affect costs, margins, and the ability to bring products to market reliably.

gdufa regulatory

"ahead of its Generic Drug User Fee Act (GDUFA) goal date"

GDUFA is a U.S. regulatory program that charges fees to makers of generic drugs to fund and speed up the government review and inspection process for generic medicines and manufacturing sites. For investors, it matters because the program influences how fast generics reach the market, the cost burden on manufacturers, and the ability of companies to scale production—similar to paying for faster processing at a government office that can affect a business’s timing and margins.

benzethonium chloride medical

"contains no benzethonium chloride (BZT), a toxic antimicrobial preservative"

Benzethonium chloride is a synthetic antimicrobial compound used as a disinfectant, preservative and antibacterial ingredient in personal care, household and medical products. It works like a tiny soap molecule that disrupts and kills germs, which makes it valuable for formulations that need long-lasting protection. Investors watch it because changes in safety reviews, regulations, supply or demand can affect sales, manufacturing costs and the reputations of companies that use it.

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• Preservative-Free Ketamine is an American-manufactured presentation of ketamine that contains no benzethonium chloride (BZT), a toxic antimicrobial preservative that is not Generally Recognized as Safe (GRAS) by the FDA. Current law requires preservatives and other inactive ingredients of drugs, foods, and cosmetics to be GRAS or demonstrated to be unsafe.
• Benzethonium Chloride is known to be toxic to the cells that line the body’s organs (epithelial cells) and is banned from new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs ^1,2
• Ketamine, originally formulated in 1970 is one of the last remaining sterile drugs to contain Benzethonium Chloride.
• NRx aims to return sterile, injectable drug manufacture to the United States and to end the current shortage of traditional glass-bottled ketamine through modern, high-volume “blow-fill-seal” technology, manufactured in the United States with Nephron Pharmaceuticals in West Columbia, South Carolina.
• This approval demonstrates that sterile, injectable drug manufacturing can be reshored to the United States from current overseas sources of supply using modern technology for the benefit of American patients, workers, and their families.
• The Company will host a conference call Friday, October 30, at 8:30 a.m. ET.
  
  

WILMINGTON, Del., Oct. 30, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a commercial biopharmaceutical company developing medicines that target depression, PTSD, and suicidality today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine. The approval comes ahead of the FDA-announced November 10, approval goal date.

“We are excited to bring Preservative-Free Ketamine to market and to give patients and their physicians an option for repeat treatments without the potential dangers of a preservative that has been classified as unacceptable for inclusion in multiple product categories by the US Food and Drug Administration,” said Jonathan Javitt, MD, MPH, the company’s Chairman and Chief Executive Officer. “Ketamine injection has been in short supply since 2018 and currently appears on the FDA drug shortage list with some manufacturers discontinuing production. The Secretary of Health and FDA Commissioner have previously identified ketamine as a strategic drug whose supply in the US must be assured. With manufactured commercial supply on hand, we can now label our product and supply American hospitals and clinics. In those settings, ketamine is used primarily for anesthesia and pain control, including in labor and delivery, where it is the only IV anesthetic that minimizes suppression of breathing in the baby. We are pleased to work with our partners at Nephron Pharmaceuticals in West Columbia, South Carolina, who have helped us prove that sterile, preservative-free injectables can be made in America.”

Currently all available ketamine injection products contain benzethonium chloride (BZT). According to current regulation, inactive ingredients in drugs (including preservatives) must be Generally Recognized as Safe (“GRAS”) or proven not to be unsafe. The FDA has declined to designate Benzethonium Chloride as GRAS. Under current FDA policy, benzethonium chloride cannot be included in new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs nor in intravenous formulations above a threshold concentration for toxicological reasons.^1,2 Ketamine is one of the few remaining old drugs, initially formulated in 1970 to contain BZT. Prior to NRx’s novel formulation, it was widely believed that BZT was required for long-term stability and sterility of ketamine.

The Company has filed a Citizen Petition with FDA seeking to have BZT removed from ketamine and an expert Toxicology report is available to the public on the FDA docket. That report, compiled by a Board-Certified Toxicologist under the supervision of a leading Regulatory Law Firm, documents that patients receiving ketamine at dosages routinely used in hospitals and clinics for labeled indications may be exposed to levels of BZT that exceed the published FDA maximum daily exposure of 1 milligram.²

Federal policymakers have addressed the threat to the United States of a sterile injectable drug supply that is largely manufactured offshore. Traditional, labor-intensive, glass bottle manufacturing of these drugs has not been economically viable in the United States for decades. NRx’s presentation of Ketamine demonstrates that manufacture of old-line sterile, injectable drugs can be reshored to the United States for the benefit of American patients, workers, and investors.

The approval of Ketamine ahead of its Generic Drug User Fee Act (GDUFA) goal date by the FDA Office of Generic Drugs demonstrates FDA’s commitment to timely and efficient approval of drug-shortage drugs.

Conference Call Details

The Company will host a conference call at 8:30 a.m. ET on Friday, October 30, 2026, to discuss the FDA approval of Preservative-Free Ketamine. A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally 1-646-307-1865.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company has been awarded a Abbreviated New Drug Approval (ANDA) for Preservative-Free Ketamine and is seeking New Drug Approval for a presentation of intravenous ketamine (NRX-100) with approved claims for treating depression and suicidality.

In October 2026 the Defense Advanced Research Projects Agency awarded an $11.25 million contract to NRx to conduct a phase 3 trial of its oral drug NRX-101, (D-cycloserine/lurasidone) combined with Robotic Neuronavigated Transcranial Magnetic Stimulation as a one-day treatment for patients with depression. 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.

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Brian Korb
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact:
Victoria Verdeja
RXMD
(305) 904-1038
vverdeja@rxmedny.com

References

1. U.S. Food and Drug Administration. (2019). Safety and effectiveness of consumer antiseptic rubs; topical antimicrobial drug products for over-the-counter human use. Federal Register, 84(71), 14847–14864.
2. U.S. Food and Drug Administration. (n.d.). Inactive ingredient search for approved drug products: Benzethonium chloride. Retrieved October 29, 2026, from https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
3. https://www.regulations.gov/document/FDA-2025-P-3577-0004
   

FAQ

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What did the FDA approve for NRx Pharmaceuticals’ preservative-free ketamine?

The FDA approved NRx’s Abbreviated New Drug Application, the application pathway for a generic drug, for preservative-free ketamine. The approval came ahead of the agency’s November 10 goal date. The formulation contains no benzethonium chloride.