NRx Pharmaceuticals, Inc. announced on October 30, 2026, 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 was granted ahead of the November 10, 2026, goal date established under the Generic Drug User Fee Amendments (GDUFA).
The approved product is an American-manufactured presentation of ketamine that does not contain benzethonium chloride (BZT), a toxic antimicrobial preservative that is not Generally Recognized as Safe (GRAS) by the FDA. According to current regulations, inactive ingredients in drugs must be GRAS or proven not to be unsafe. The FDA has declined to designate Benzethonium Chloride as GRAS, and it is banned from new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs, and intravenous formulations above a specific threshold concentration.
Ketamine injection has been in short supply since 2018 and is currently listed on the FDA drug shortage list. NRx aims to address this shortage by returning sterile, injectable drug manufacture to the United States using modern, high-volume “blow-fill-seal” technology. The product is manufactured in West Columbia, South Carolina, in partnership with Nephron Pharmaceuticals.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is also seeking New Drug Approval for a presentation of intravenous ketamine (NRX-100) with approved claims for treating depression and suicidality.
