NRx Pharma says FDA reclassifies ketamine ANDA amendment as minor, sets Nov. 10, 2026 goal date

NRX Pharmaceuticals said it received FDA notice reclassifying its ketamine ANDA amendment from major to minor, easing the review burden.

The FDA also reset the GDUFA target action date to Nov. 10, 2026.

The shorter review timeline could accelerate potential clearance of preservative-free ketamine, a product tied to U.S. drug-shortage demand.