Ketamine is approved by the US Food & Drug Administration for use in humans as an anesthetic agent and as an analgesic agent to supplement low-potency medications such as nitrous oxide. The use of ketamine for treatment resistant depression is considered “off-label” by the FDA. Once a drug is approved by the FDA for one indication, then clinicians may use that same medication for other indications if they feel that the evidence supports the practice. Ketamine is off-label because no one has invested the millions of dollars necessary to go through the multi-phase process of getting ketamine “approved” by the FDA for these indications. The fact that ketamine is a generic medication means that it is unlikely that any company or organization will EVER spend the money to get ketamine “FDA approved.” The issue of whether there is good evidence to support the use of ketamine for the indications for which Klarisana is using it is separate from the simple discussion of FDA approval. There are many medications that are prescribed and administered every day that are off-label. For example, Compazine (prochlorperazine) is indicated for nausea but frequently used to treat migraine headaches. A common misconception is that just because a medication is not “FDA Approved” for a certain indication that this means the FDA has prohibited its use for that indication. If the FDA wanted to prevent the use of a medication they would issue a “black box” warning; this is not the case for ketamine.