NRX Pharmaceuticals Inc. has announced a significant regulatory development for their product, NRX-100, a preservative-free IV ketamine formulation. In April 2025, the FDA granted a waiver of the $4.3 million New Drug Application (NDA) fee under the Prescription Drug User Fee Act (PDUFA), acknowledging the product's public health value and NRx's qualification under small business provisions. NRX-100 has previously received Fast Track Designation in conjunction with NRX-101, and with regulatory filings underway, the company is seeking priority review due to the ongoing ketamine shortage in the U.S. This waiver is specific to NRx Pharmaceuticals and highlights the FDA's recognition of the innovative approach the company is taking to eliminate toxic preservatives from ketamine formulations.
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