NRx Pharmaceuticals reports the FDA has identified no bioequivalence deficiencies in its ANDA for preservative-free ketamine, with a potential approval decision expected in summer 2026.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
NRx Pharmaceuticals announced that the Bioequivalence Program within the U.S. Food and Drug Administration Office of Generic Drugs has informed the company that it has not identified any bioequivalence deficiencies in the company’s Abbreviated New Drug Application (ANDA) for its preservative-free ketamine formulation. The determination remains preliminary and subject to final supervisory review, with a regulatory decision anticipated in summer 2026.
The investigational product is designed as the first ketamine formulation free of benzethonium chloride (BZT), a quaternary amine preservative historically used in ketamine products. BZT is not classified by the FDA as Generally Recognized as Safe (GRAS) and has been removed from several topical consumer applications due to safety concerns. Conventional ketamine formulations containing BZT date back to earlier periods when the safety profile of such preservatives was less clearly understood.
NRx’s formulation aims to eliminate the preservative while maintaining product stability and sterility. The company expects to demonstrate up to three years of room-temperature stability for the preservative-free formulation. Historically, it had been assumed that BZT was necessary to maintain ketamine stability and sterility under standard storage conditions. NRx has filed patent applications in the United States and internationally covering the preservative-free formulation, positioning the product as a potential “branded generic” version of ketamine.
The product is being manufactured in the United States, aligning with broader regulatory efforts to strengthen domestic supply chains for critical medicines. The FDA has recently emphasized the strategic importance of ketamine and supported initiatives aimed at establishing U.S.-based manufacturing capacity for the drug substance.
Dr. Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals, said the company appreciates the FDA’s timely review and looks forward to continued collaboration as it advances the preservative-free formulation manufactured in the United States. He added that the approach could modernize ketamine therapy while supporting supply chain resilience.
Separately, NRx is also preparing a New Drug Application under Fast Track designation seeking to expand the use of intravenous ketamine for patients with severe depression who may experience suicidal ideation.
Reference:
NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application, 17 March 2026, https://ir.nrxpharma.com/news-releases/news-release-details/nrx-pharmaceuticals-nasdaqnrxp-announces-fda-bioequivalence
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.