FDA Reclassifies NRx Pharmaceuticals' ANDA Amendment for Preservative-Free Ketamine as Minor, Setting GDUFA Goal Date of November 10, 2026
核心洞察
The FDA Office of Generic Drugs has reclassified an amendment to NRx Pharmaceuticals' ANDA for preservative-free ketamine from a Major Amendment to a Minor Amendment.
The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require substantial FDA resources.
NRx Pharmaceuticals is developing NRX-100, a preservative-free intravenous ketamine, which holds Fast Track Designation for suicidal ideation in depression, including bipolar depression (搜索).
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced on September 15, 2026, that the FDA Office of Generic Drugs has reclassified an amendment to its Abbreviated New Drug Application (ANDA) for preservative-free ketamine from a Major Amendment to a Minor Amendment. The amendment relates to the drug vial for preservative-free ketamine.
The company received written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising of the reclassification. The acknowledgement letter revised the Generic Drugs User Fee Act (GDUFA) goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.
Regulatory Significance
The reclassification from Major to Minor Amendment signals a reduced regulatory burden for the application, as the FDA determined the amendment would not demand significant agency resources. The revised GDUFA goal date of November 10, 2026, establishes the timeline for the agency's review decision on the ANDA.
"On behalf of our patients and our shareholders, we are deeply appreciative of the speed with which FDA's leadership has moved to advance the approval process of this strategic, drug shortage product," said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals.
NRX-100 Development Program
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression (搜索), chronic pain (搜索), and PTSD (搜索). The company's lead candidate, NRX-100 (preservative-free intravenous ketamine), has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression (搜索).
The company has filed an ANDA and initiated a New Drug Application (NDA) filing for NRX-100, along with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression (搜索).
Broader Pipeline and Subsidiaries
In addition to NRX-100, NRx Pharmaceuticals is developing NRX-101 (oral D-cycloserine/lurasidone), which has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression (搜索).
HOPE Therapeutics (搜索), a subsidiary of NRx Pharmaceuticals, provides advanced psychiatric and neurological care, specializing in evidence-based treatments for major depressive disorder, anxiety, and other complex neurological conditions. The subsidiary operates state-of-the-art clinics focused on improving patient outcomes through the application of modern medical technologies and clinical practices.
ZETA SURGICAL (搜索), also referenced in the company's disclosure, is focused on image-guided surgery and targeted neuro-therapeutics. Its navigation and robotics platform applies artificial intelligence and computer vision to enable high-accuracy image guidance. The Zeta Navigation System, Zeta TMS Navigation System, and Zeta TMS Robotic System are cleared by the FDA and commercially available in the United States.