NRx Pharmaceuticals Reports FDA Reclassifies Ketamine Amendment As Minor

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. FDA has reclassified an amendment to its Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free intravenous ketamine formulation, from a Major Amendment to a Minor Amendment.

Further, the FDA also revised the Generic Drug User Fee Act (GDUFA) goal date for the application to November 10, 2026, noting that the reclassified amendment would not require a substantial expenditure of agency resources.

The amendment concerns the luer-lock vial used for NRX-100. In August, the FDA completed its first-cycle review and reported no major deficiencies related to the drug product, ingredients, labeling, or manufacturing, with the remaining issue involving certification of the vial's connection to a syringe.

NRx subsequently submitted the requested manufacturer certification. The company said the vial is already used in three FDA- approved ANDA products and testing of more than 3,500 vials from seven lots showed no failures in operation of the tip.

Separately, NRx is developing NRX-100 under a New Drug Application (NDA) for the treatment of depression with suicidal ideation, including bipolar depression. The FDA has granted Fast Track designation to NRX-100 for this indication.

Chairman and Chief Executive Officer (CEO) of NRx, Jonathan Javitt said, "The company is grateful for the FDA's progress in advancing the review of NRX-100."

NRXP closed Wednesday's trade at $3.40, down 2.58%.