NRx Pharmaceuticals Announces Receipt of FDA Labeling Review Letter for Preservative-Free Ketamine
Key Highlights
- ➤NRx receives FDA letter requesting MINOR label changes for preservative-free ketamine
- ➤November 10, 2026, GDUFA goal date remains the review target
- ➤FDA requests sample labels using proprietary name currently under review
- ➤NRx is completing final manufacturing Process Validation Runs for launch requirements
Expert Statements
Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals
“We at NRx deeply appreciate the engagement of the FDA Office of Generic Drugs and their focus on completing review of our product by the GDUFA goal date.”
Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals
“The supply of ketamine in the United States has been primarily from overseas manufacture and American hospitals and doctors have been plagued by repeated shortages of this critically important drug.”
Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals
“We look forward to demonstrating that manufacture of drugs such as this can successfully be re-shored to the United States.”
Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals
“We believe that making a preservative-free preparation of ketamine is important for patients and appreciate the willingness of FDA to work with us on an appropriate product name.”
* In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as “MINOR.” * NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA. * NRx is currently completing final manufacturing Process Validation Runs to comply with product launch requirements. WILMINGTON, Del., Oct. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the receipt of a “DISCIPLINE REVIEW LETTER” from the US Food and Drug Administration requesting “MINOR” changes to the submitted label for NRx’s Preservative-Free Ketamine product. The letter requests that the Company submits sample labeling with the proposed proprietary product name currently under review in advance of the November 10, 2026, Abbreviated New Drug Application GDUFA goal date.
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