NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine

In April 2025, the FDA granted a waiver of the $4.3 million NDA fee under the PDUFA, recognizing both the product's public health value and NRx's qualification under small business provisions. NRX-100 was previously granted Fast Track Designation in a protocol with NRX-101. With regulatory filings underway, patent protection sought through 2045, and a growing body of clinical and technical validation, NRx believes NRX- 100 is well-positioned to become a next-generation standard in both the emerging mental h ...