NRx Pharmaceuticals Wins FDA Approval for Preservative-Free Ketamine Ahead of November 10 Deadline

NRx Pharmaceuticals received FDA approval for its generic preservative-free ketamine injection, branded as KETAFREE, on October 30, beating the agency's November 10 GDUFA goal date. The company filed an Abbreviated New Drug Application for the product in September 2025, and the FDA completed its first-cycle review with no drug-related major deficiencies before issuing final approval.

The approval covers a preservative-free formulation of ketamine for intravenous infusion, positioned as a generic alternative in the existing ketamine market. NRx said commercial supply is ready for hospitals and clinics, meaning the company can begin selling immediately rather than waiting to build inventory after approval.

Shares of NRXP jumped roughly 13.9% in premarket trading on the news. The ketamine ANDA approval is separate from NRx's ongoing pursuit of a New Drug Application to use its ketamine formulation, NRX-100, for treating suicidal depression, a program that carries FDA Fast Track designation.