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What does FDA approved mean?
It takes approximately $100 million dollars to run the clinical trials necessary to have the FDA approve a medication for a specific indication, like depression. Once a medication is approved for a certain use and then becomes generic - there is no financial incentive to spend another $100 million dollars expanding the use to include other conditions like anxiety or PTSD - because the pharmaceutical company wouldn’t have a patent. Esketamine has an FDA label, because Janssen pharmaceutical spent that money to be able to patent eksetamine’s use. But is actually any better than the original formulation of ketamine? There’s no data to support that. The fact is generic ketamine works and doctor’s use medications off-label all the time, safely and cost-effectively based on accumulating evidence and experience.
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What does FDA approval mean?
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