FDA reclassifies NRx Pharmaceuticals ketamine application amendment
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NRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine
September 15, 2026 3:11 PM EDTAbbreviated 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... More
