NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine

  • Ketamine faces a current US drug shortage not expected to abate in the near future1 Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.2  NRx anticipates marketing ketamine for all approved uses Company anticipates priority review based on current and anticipated drug shortage NRX-100 to provide innovative, preservative-free IV ketamine formulation to eliminate benzethonium chloride preservative, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs The Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from all presentations of ketamine intended for intravenous use This filing complements the ongoing NDA submission for NRX-100 in suicidal depression; PDUFA anticipated in late 2025 WILMINGTON, Del. , June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management.