NRx Pharmaceuticals, Inc. announced on September 15, 2026, that the U.S. Food and Drug Administration (FDA) has reclassified an amendment to its Abbreviated New Drug Application (ANDA) from a Major Amendment to a Minor Amendment. The update was communicated in a letter from the Director of Regulatory Operations at the FDA Office of Generic Drugs.
The reclassification was accompanied by a revised Generic Drug User Fee Act (GDUFA) goal date of November 10, 2026. The FDA stated that the amendment does not require a substantial expenditure of resources.
The ANDA in question relates to NRX-100, a preservative-free intravenous ketamine product. NRx Pharmaceuticals is developing NRX-100 for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The company has noted that NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform. The company also filed a New Drug Application for NRX-100 and initiated an application for the Commissioner's National Priority Voucher Program.
