FDA requests minor labeling changes for NRx Pharmaceuticals' preservative-free ketamine
NRXP•NRx Pharmaceuticals received an FDA review letter requesting minor labeling changes for its preservative-free ketamine product. The FDA requested sample labeling using the proposed proprietary name ahead of the November 10, 2026, review deadline; final manufacturing process validation runs are underway.
1. FDA review request
NRx Pharmaceuticals received an FDA review letter requesting minor labeling changes for its preservative-free ketamine product. The FDA requested sample labeling using the proposed proprietary name, which remains under review, ahead of the November 10, 2026, review deadline; final manufacturing process validation runs are underway.
