Product DevelopmentNRx Pharmaceuticals has refiled an Abbreviated New Drug Application (ANDA) for KETAFREE, their preservative-free ketamine, which could benefit from priority review due to the national drug shortage of ketamine.
Regulatory ApprovalsFDA’s approval of UZEDY underscores a more flexible, data-integrated regulatory stance in psychiatry—directly supportive of NRx’s filing strategy for NRX-100 and NRX-101.
Regulatory SupportThe FDA’s actions reinforce a clear policy direction toward addressing suicidality and serious mood disorders as public health priorities—a stance that aligns with NRx-100’s expanded Fast Track designation.