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NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026.NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.Current worldwide generic ketamine market is estimated at $750 million per year.NRx has manufactured initial registration lots of KETAFREE™ and is prepared to scale manufacturing to 1 million vials per month.NRx is awaiting a response to its Citizen Petition filed in August with the FDA seeking the removal of Benzethonium Chloride preservative from all forms of ketamine sold in the United States WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has received the Company’s Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation. The acknowledgement letter states that the FDA has “made a threshold determination that this ANDA is substantially complete” and issued a goal date of July 29, 2026 for completion of the final review with potential marketing approval. “We appreciate FDA’s careful review and are pleased that it has received our application for KETAFREE™, an important milestone in our effort to bring a single-patient, preservative-free presentation of ketamine to the patients and clinicians who depend on this medicine,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “Current ketamine products are typically supplied in multi-dose vials that contain a preservative called Benzethonium Chloride (BZT) that is not recognized as safe by FDA and banned from hand cleansers and topical antiseptics. BZT was originally added to ketamine and other sterile injectable products in the 1970s at a time when multidose vials of medication were used to treat several patients, a practice that is no longer allowed in US healthcare facilities. BZT is no longer added to new sterile products. The current MAHA initiatives have called for review and removal of toxic substances from foods, drugs, and...