WILMINGTON, Del., June 5, 2025 - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, announced a significant milestone with the submission of its Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for NRX-100, a preservative-free IV ketamine formulation. This submission aligns with the company's efforts to address the ongoing ketamine shortage in the U.S., which is not expected to resolve soon. The innovative formulation, designed to replace older versions containing potentially harmful preservatives, is anticipated to receive priority review due to the current and anticipated drug shortage. NRx Pharmaceuticals is also preparing a citizen's petition to eliminate benzethonium chloride from all intravenous ketamine products. This regulatory step comes as part of NRx's broader strategy to secure a foothold in the expanding ketamine market, expected to grow to $3.35 billion globally by 2034. The FDA previously waived a $4.3 million NDA fee for NRX-100, recognizing its public health value and NRx's qualification under small business provisions.
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