NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine

Core Viewpoint - NRx Pharmaceuticals has received acknowledgment from the FDA for its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation, with a goal date for final review set for July 29, 2026 [1][8]. Company Developments - The FDA has determined that the ANDA for KETAFREE™ is "substantially complete," marking a significant milestone for the company [1][8]. - KETAFREE™ aims to provide a single-patient, preservative-free ketamine option, addressing safety concerns associated with the current multi-dose vials containing Benzethonium Chloride (BZT), which is not recognized as safe by the FDA [2][3]. - The company has manufactured initial registration lots of KETAFREE™ and is prepared to scale production to 1 million vials per month [8]. Market Context - The global generic ketamine market is estimated to be worth $750 million annually, indicating a substantial market opportunity for KETAFREE™ upon approval [8]. - The current healthcare initiatives are focused on the review and removal of toxic substances from drugs, aligning KETAFREE™ with these priorities [4]. Future Outlook - The next key milestone for NRx Pharmaceuticals is the completion of the FDA review under the Generic Drug User Fee Amendments framework, with the GDUFA goal date also set for July 29, 2026 [5][8]. - The company is also advancing its pipeline, including the development of NRX-100 for suicidal depression, which has received Fast Track designation from the FDA [5][7].