WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has not identified bioequivalence deficiencies in its abbreviated new drug application for a preservative-free ketamine product, a step toward potential approval expected in summer 2026.
The company said it received written correspondence from the FDA’s Office of Generic Drugs indicating no bioequivalence issues “at this time,” noting the determination remains preliminary pending final supervisory review.
The application was submitted under the abbreviated new drug application, or ANDA, pathway, which requires a generic product to demonstrate it is equivalent to an existing approved drug.
NRx said it continues to expect a decision under the Generic Drug User Fee Amendments program in summer 2026, as previously disclosed.
The company’s formulation is designed to exclude benzethonium chloride, a preservative used in some existing ketamine products.
NRx said its product is intended to offer a preservative-free alternative in the current ketamine market and is manufactured in the United States.
The ANDA filing is separate from the company’s efforts to seek approval of ketamine as a treatment for depression through a new drug application reviewed by the FDA’s Division of Psychiatry Products.
“We look forward to an ongoing collaborative relationship,” CEO Jonathan Javitt said, referring to the FDA’s review process.
NRx said it is also preparing a separate new drug application under Fast Track designation to evaluate intravenous ketamine for patients with severe depression, including those with suicidal ideation.
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