FDA Accepts NRx Pharmaceuticals' ANDA for KETAFREE with Review Goal Date Set
NRx Pharmaceuticals announced the FDA's acceptance of its ANDA for KETAFREE™, a preservative-free intravenous ketamine formulation. The FDA set a review goal date of July 29, 2026, for potential marketing approval. KETAFREE™ is the first formulation without Benzethonium Chloride, a preservative not recognized as safe by the FDA.
NRx Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has received and deemed substantially complete its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation. The FDA has assigned a Generic Drug User Fee Amendments (GDUFA) goal date of July 29, 2026, for completion of the final review and potential marketing approval. KETAFREE™ is positioned as the first preservative-free ketamine formulation without Benzethonium Chloride, a preservative not recognized as safe by the FDA. The regulatory review is specific to NRx Pharmaceuticals Inc. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595024-en) on December 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
