Yes, ketamine itself is FDA-approved. The FDA initially approved ketamine in 1970 as an anesthetic agent. It is commonly used in medical and surgical settings for anesthesia due to its safety profile, especially in patients at risk of respiratory depression.

Although ketamine is not FDA-approved for depression or other psychiatric conditions, it is frequently used off-label in medical settings to treat severe, treatment-resistant depression, PTSD, and other mental health disorders.

Off-label use allows clinicians to prescribe ketamine based on their professional judgment and the existing evidence supporting its effectiveness for these conditions.