FDA reclassifies NRx Pharmaceuticals ketamine application amendment

NRx Pharmaceuticals (NASDAQ: NRXP) announced that the FDA has reclassified an amendment to its Abbreviated New Drug Application (ANDA) for preservative-free ketamine from a Major Amendment to a Minor Amendment.

The FDA's Office of Generic Drugs communicated the reclassification in writing, noting that the amendment will not require a substantial expenditure of FDA resources. The agency revised the Generic Drugs User Fee Act (GDUFA) goal date to November 10, 2026.

"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.

The ANDA amendment pertains to the drug vial for NRX-100, the company's preservative-free intravenous ketamine product. NRx has also initiated a New Drug Application filing for NRX-100 and applied for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

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