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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Re-Files Abbreviated New Drug Application (ANDA) for KETAFREE™, Preservative-Free IV Ketamine
KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugsFiling is based on FDA interaction and approval of Suitability Petition for NRx’s proposed strength of preservative-free ketamineThis presentation of ketamine represents a reshoring of a strategically important drug to the US, in keeping with the Presidential Executive Order signed on May 5, 2025. Ketamine faces a current US drug shortage not expected to abate in the near future1Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.2 NRx anticipates marketing KETAFREE™ for currently approved ketamine indicationsThe Company has filed 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 useThis formulation of ketamine is distinct from the formulation used in the ongoing NDA submission for NRX-100 in suicidal ideation in depressed patients, including bipolar depression, which was recently granted Fast Track designation by the FDA WILMINGTON, Del., Sept. 29, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the re-filing of its Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for KETAFREE™, its preservative-free IV ketamine formulation, for use in all existing approved indications. The filing follows FDA grant of approval of its Suitability Petition for NRx’s proposed strength of preservative-free ketamine. The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. This does not include the widespread use of compounded ketamine by clinics unable to obtain manufactured drug. NRx aims to capture a significant share of the current market. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime3, a number that continues to grow with increased clinical focus on this important medication. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacists. Accordingly, NRx is seeking...