FDA Completes First-Cycle Review of Preservative-Free Ketamine ANDA with No Major Drug-Related Deficiencies

NRx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has completed its first-cycle review of the company's Abbreviated New Drug Application (ANDA) for preservative-free ketamine. The review identified no major deficiencies related to the drug product, ingredients, proposed labeling, or manufacturing controls. The remaining requirement for approval is a manufacturing certification for a luer lock vial.