WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently received a Discipline Review Letter from the U.S. Food and Drug Administration identifying only minor administrative changes for its ketamine application and held a meeting with FDA leadership supporting potential approval within the current review cycle.
The review letter, issued by the FDA’s Office of Generic Drugs, addressed drug quality, including manufacturing and microbiology, and requested updates to prior stability data.
The company said the feedback follows a previously reported favorable bioequivalence determination on March 17, 2026, as part of its Abbreviated New Drug Application.
NRx also met with FDA leadership, which expressed support for completing the review within the current cycle, with a target approval timeframe in summer 2026.
The company said the review process aligns with a recent executive order directing agencies to accelerate approvals for treatments addressing severe depression, suicidality, and post-traumatic stress disorder.
NRx’s ketamine formulation does not include benzethonium chloride, a preservative not permitted in new drug formulations under current FDA policy.
Ketamine has been identified by the U.S. Department of Veterans Affairs as medically necessary for certain patients with treatment-resistant depression and suicidality.
Jonathan Javitt, chief executive officer of NRx, said the company is working with regulators to advance the application.
NRx is also preparing a separate New Drug Application to align labeling for ketamine with its use in treating depression and suicidality.
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