The FDA reclassified NRx Pharmaceuticals’ preservative-free ketamine ANDA amendment from major to minor and set a revised GDUFA goal date of 10 November 2026.

The amendment concerns the drug vial for NRX-100, NRx’s preservative-free intravenous ketamine product. The FDA said the minor amendment would not require substantial agency resources, reducing the expected review burden, while NRx continues development through its subsidiary HOPE Therapeutics.