NRx Pharmaceuticals (Nasdaq:NRXP) Receives FDA Approval of Preservative-Free Ketamine Ahead of November 10 FDA Goal Date
Key Highlights
- ➤NRx Pharmaceuticals (NRXP) receives FDA approval for preservative-free ketamine
- ➤FDA approval arrives ahead of November 10 GDUFA goal date
- ➤NRx plans U.S. supply using Nephron’s blow-fill-seal manufacturing technology
- ➤Ketamine injection remains on FDA drug shortage list since 2018
- ➤DARPA awarded NRx an $11.25 million contract for NRX-101 phase 3 trial
Expert Statements
Jonathan Javitt, Chairman and Chief Executive Officer of NRx Pharmaceuticals
“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.”
Jonathan Javitt, Chairman and Chief Executive Officer of NRx Pharmaceuticals
“Ketamine injection has been in short supply since 2018 and currently appears on the FDA drug shortage list with some manufacturers discontinuing production.”
Jonathan Javitt, Chairman and Chief Executive Officer of NRx Pharmaceuticals
“The Secretary of Health and FDA Commissioner have previously identified ketamine as a strategic drug whose supply in the US must be assured.”
Jonathan Javitt, Chairman and Chief Executive Officer of NRx Pharmaceuticals
“With manufactured commercial supply on hand, we can now label our product and supply American hospitals and clinics.”
Jonathan Javitt, Chairman and Chief Executive Officer of NRx Pharmaceuticals
“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.”
* 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.
Get started
Create a free account to read the full story.