Core Viewpoint - NRx Pharmaceuticals has re-filed its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free IV ketamine formulation, following FDA approval of its Suitability Petition for the proposed strength of the drug [1][6]. Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6]. - An estimated 5.1 million Americans have received ketamine for medical uses, a number that continues to rise due to increased clinical focus [2]. Company Developments - NRx Pharmaceuticals aims to capture a significant share of the ketamine market and is seeking priority review from the FDA due to a severe drug shortage [2][4]. - The company has filed a citizen's petition to remove benzethonium chloride (BZT), a neurotoxic substance, from ketamine formulations intended for intravenous use [3][6]. - NRx's KETAFREE™ formulation is designed to eliminate toxic preservatives, aligning with current health priorities to remove harmful substances from drugs [6][7]. Manufacturing and Regulatory Context - The manufacturing of KETAFREE™ is in partnership with Nephron Pharmaceuticals, supporting the U.S. initiative to reshore critical drugs [4][6]. - The ANDA formulation is distinct from the New Drug Application (NDA) for NRX-100, which has received Fast Track Designation for treating suicidal ideation in depression [5][6]. Clinical Data and Future Prospects - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients, demonstrating the efficacy of ketamine compared to placebo and electroconvulsive therapy [5][6].