NRX PHARMACEUTICALS (NRXP) Says FDA Downgraded Ketamine Filing Amendment
The FDA reclassified an amendment to NRx's generic application for preservative-free IV ketamine as minor, setting a GDUFA goal date of November 10, 2026.
NRx Pharmaceuticals (NRXP) said on September 15, 2026 that the FDA's Office of Generic Drugs has reclassified an amendment to its Abbreviated New Drug Application for preservative-free intravenous ketamine from a Major Amendment to a Minor Amendment. The change came in a written communication from the agency's Director of Regulatory Operations.
