NRx Pharmaceuticals received an FDA review letter requesting only minor labelling changes for preservative-free ketamine NRX-100 ahead of the 10 November 2026 GDUFA goal date.

The FDA requested minor label changes and submission of labels using NRX-100’s proprietary product name, which remains under review. NRx Pharmaceuticals is completing final manufacturing process validation runs and aims to re-shore ketamine supply to the US.