India, Oct. 15 -- NRx Pharmaceuticals Inc. (NRXP) announced Thursday that it has received a Discipline Review Letter from the U.S. Food and Drug Administration (FDA) requesting minor changes to the labeling of its preservative-free ketamine product.
The FDA requested that the company submit sample labeling featuring the proposed proprietary product name currently under review ahead of the November 10, 2026, Generic Drug User Fee Amendments (GDUFA) goal date.
NRx is developing NRX-100, a preservative-free intravenous ketamine formulation intended for use in patients with depression, including bipolar depression. The product is being developed within the company's broader NMDA receptor platform targeting central nervous system disorders, in...