NRX Pharma Nears FDA Approval for Ketamine Drug After Positive Label Review

NRX Pharmaceuticals received encouraging feedback from the FDA’s Office of Generic Drugs, with only minor formatting comments on the proposed label for its preservative-free ketamine product. The company expects to submit its final label shortly as it moves closer to potential approval.

With anticipated approval as early as summer 2026, the therapy could help expand U.S. ketamine supply at a time of shortages, positioning NRX to play a key role in addressing growing demand for mental health and medical treatments.

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