that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective.

This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is often extensive medical literature to support the off-label use.

A leading example of how regulatory agencies

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