Ketamine infusions do not meet the strict criteria set by the FDA to be “approved” for treating depression and other conditions. When drugs are approved for use by the FDA, they are generally done so for only the narrow range of conditions studied when they are undergoing development.
For ketamine, that dates back almost 50 years, decades before it was known to help many patients with depression and other conditions; thus, the approval for ketamine by the FDA has always been an anesthetic agent. Esketamine, the nasal form of ketamine (also called Spravato), which was developed and studied for the express purpose of treating depression, has been given FDA approval for the treatment of depression, thereby demonstrating that the FDA recognizes the ability of ketamine to benefit patients with that condition.
Many of the drugs doctors commonly prescribe for their patients are not “FDA approved,” but like ketamine, there is a wealth of medical literature demonstrating their safety and effectiveness.