• Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.
  • FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026.

WILMINGTON, Del., Sept. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified as a Minor Amendment.

The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.