NRx Pharmaceuticals Inc. (NASDAQ: NRXP) received written notice that the Food and Drug Administration has reclassified an amendment to its Abbreviated New Drug Application for preservative-free ketamine, designated NRX-100, from a Major Amendment to a Minor Amendment.
The FDA’s Director of Regulatory Operations of the Office of Generic Drugs communicated the change to the Wilmington, Delaware–based company. In its correspondence, the agency stated the reclassified amendment will not require a substantial expenditure of FDA resources.
Under the Generic Drugs User Fee Act, the revised goal date for FDA review is now November 10, 2026. The company announced the update Monday.
NRX-100 is being developed as a clinical-stage biopharmaceutical product for the treatment of suicidal ideation in depression, including bipolar depression. The FDA has granted Fast Track Designation for the indication.
NRx Pharmaceuticals has filed an ANDA for preservative-free ketamine and initiated a separate New Drug Application filing for NRX-100. The company has also submitted an application for the Commissioner’s National Priority Voucher Program.
