Wilmington, Delaware, US — October 30, 2026
NRx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine, ahead of the agency’s November 10 approval goal date. The approved formulation is designed without benzethonium chloride (BZT), an antimicrobial preservative included in conventional ketamine injection products. NRx said the approval supports its efforts to introduce a preservative-free presentation and expand domestic production of sterile injectable medicines. The product is manufactured in the United States in collaboration with Nephron Pharmaceuticals in West Columbia, South Carolina, using modern blow-fill-seal technology. The company stated that commercial supply is available and that it can proceed with product labeling and supply to US hospitals and clinics. Ketamine injection has experienced supply constraints since 2018, with some manufacturers discontinuing production. NRx believes its approval demonstrates the potential to restore domestic manufacturing capacity for established sterile injectable medicines while providing an alternative formulation for clinical use.
Preservative-Free Formulation and FDA Approval
The newly approved formulation removes BZT, which NRx describes as a toxic antimicrobial preservative with limitations on its use in several regulated product categories. The company noted that inactive ingredients in drug products, including preservatives, must meet applicable safety requirements, including being generally recognized as safe (GRAS) or otherwise demonstrated to be safe under the relevant regulatory framework. According to NRx, the FDA has not designated benzethonium chloride as GRAS. The company also stated that BZT is restricted or prohibited in certain products, including new drugs, consumer hand cleansers, wipes and healthcare or surgical hand rubs, as well as in intravenous formulations above specified concentrations. Ketamine, first formulated in 1970, has continued to contain BZT in conventional injectable presentations. NRx said its formulation was developed to maintain stability and sterility without relying on this preservative. The company has also filed a Citizen Petition with the FDA seeking removal of BZT from ketamine products. An expert toxicology report submitted to the FDA docket reportedly discusses potential patient exposure at routinely used ketamine doses, including exposure that may exceed the published FDA maximum daily exposure cited by the company. These are company-reported concerns; the approval announcement does not establish that existing ketamine products cause clinical harm.
US Manufacturing and Ketamine Supply
NRx is working with Nephron Pharmaceuticals to manufacture the approved product in West Columbia, South Carolina, using blow-fill-seal technology. This manufacturing process is intended to support high-volume production of sterile injectable medicines through an automated approach. NRx said the collaboration demonstrates that certain established injectable drugs can be manufactured domestically using modern production technology rather than relying primarily on traditional, labor-intensive glass-bottle manufacturing. The company highlighted the importance of strengthening US supply chains for sterile injectable medicines, many of which have historically depended on overseas manufacturing. Ketamine injection is used in clinical settings primarily for anesthesia and pain management. NRx also cited its use in labor and delivery, noting its respiratory-sparing properties as part of the rationale for its role in selected clinical settings. The company said commercial supply is already on hand and that the FDA approval allows it to move toward labeling and distribution to hospitals and clinics. The approval ahead of the Generic Drug User Fee Amendments (GDUFA) goal date also reflects the agency’s timely review of the application, according to NRx.
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NRx Pipeline and Next Steps
NRx Pharmaceuticals said it plans to discuss the approval and commercialization progress during a conference call scheduled for October 30, 2026, at 8:30 a.m. Eastern Time. The company is also developing medicines targeting central nervous system disorders, including depression, post-traumatic stress disorder (PTSD), suicidality and chronic pain, through its NMDA receptor platform. Its investigational programs include NRX-100, an intravenous ketamine presentation for which the company is seeking New Drug Application approval with proposed claims relating to depression and suicidality, and NRX-101, an oral combination of D-cycloserine and lurasidone. NRX-100 has received FDA Fast Track designation for suicidal ideation in depression, including bipolar depression, while NRX-101 has received Breakthrough Therapy designation for suicidal bipolar depression. In October 2026, the Defense Advanced Research Projects Agency (DARPA) awarded NRx an $11.25 million contract to conduct a Phase 3 trial evaluating NRX-101 in combination with robotic neuronavigated transcranial magnetic stimulation as a one-day treatment approach for patients with depression. The company said the Preservative-Free Ketamine approval represents a manufacturing and commercial milestone alongside its broader development programs. Further progress will depend on product launch execution, supply delivery and continued regulatory development of its investigational pipeline.
Source:NRx Pharmaceuticals Press release
