WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) recently received preliminary feedback from the U.S. Food and Drug Administration on labeling for its preservative-free ketamine product, as the company continues to seek approval for the drug.
The FDA Office of Generic Drugs indicated alignment on the proposed label, with comments limited to minor formatting changes, according to NRx. The labeling remains subject to final supervisory review as part of the company’s Abbreviated New Drug Application.
NRx said it plans to submit a finalized label this month and continues to anticipate a decision under the Generic Drug User Fee Act in Summer 2026.
The company previously received a preliminary determination of bioequivalence for the product, a step required for approval of a generic drug.
NRx said the product could expand the supply of U.S.-manufactured ketamine, as some suppliers have reported backorders.
The drug is manufactured in the United States at a time when federal regulators have identified ketamine as a strategic product and have taken steps to encourage domestic production of key drug ingredients.
Chief Executive Officer Dr. Jonathan Javitt said the company is continuing to work with regulators on the application.
“We deeply appreciate the FDA’s timely review of the proposed labeling for our generic drug application,” Javitt said.
In addition to the pending generic drug application, NRx said it is preparing a separate New Drug Application under Fast Track designation to expand the use of intravenous ketamine for patients with severe depression, including those with suicidal ideation.
NRx is developing treatments for central nervous system disorders, including depression, chronic pain, and post-traumatic stress disorder.
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