NRx Pharmaceuticals wins FDA approval for Preservative-Free Ketamine

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said on October 30, 2026 that the FDA approved its Abbreviated New Drug Application for a product the company calls Preservative-Free Ketamine. The approval came ahead of the November 10, 2026 goal date established under the Generic Drug User Fee Amendments.¹

The product omits benzethonium chloride, an ingredient the company describes as toxic to the cells that line the body's organs and banned from new drugs, consumer hand cleansers, wipes, and healthcare or surgical hand rubs¹. The company noted that the FDA has declined to designate Benzethonium Chloride as Generally Recognized as Safe¹, and that all currently available ketamine injection products contain the preservative¹.

CEO Jonathan Javitt said the company can now supply hospitals and clinics with labeled product, noting that ketamine injection has been in shortage since 2018 and appears on the FDA's drug shortage list, with some manufacturers halting production¹. He added that federal health officials have previously flagged ketamine as a drug whose domestic supply needs to be secured¹.

NRx said it manufactures the product with Nephron Pharmaceuticals in West Columbia, South Carolina, using blow-fill-seal technology, aiming to address the glass-bottle ketamine shortage.¹ The company also disclosed it has filed a Citizen Petition asking the FDA to remove benzethonium chloride from ketamine products generally, supported by a toxicology report on the FDA docket.

Separately, the release noted that in October 2026 the Defense Advanced Research Projects Agency awarded NRx an $11.25 million contract for a Phase 3 trial of its oral drug NRX-101 combined with robotic neuronavigated transcranial magnetic stimulation as a one-day depression treatment.¹ NRx held a conference call on October 30, 2026 to discuss the ketamine approval.