Indication (Clinical)
The specific disease or condition a drug is approved to treat, as stated in its labeling.
An indication is the specific disease, condition, or patient population a drug is approved to treat, as stated in its official labeling. A single drug can carry multiple indications if it's been separately studied and approved for each one, and an approved indication is usually narrower than the underlying biology would suggest: limited to a particular stage of disease, line of therapy, or patient subgroup.
The indication is the anchor for the on-label versus off-label line. Promoting a drug for a use, population, or dosing regimen outside its approved indication is off-label promotion, regardless of how strong the supporting science might be. That's why claim review starts by checking the indication a piece of content is actually built around, before it checks anything about the claim's language or tone.