Glossary
Glossary Indication

Indication

Also known as: indications, approved indication, on-label indication
BiopharmaRegulatory

Definition

The specific condition a medicine is approved by a regulator to treat, in the exact population and use the label states — a drug is not approved in general, it is approved for an indication

This is why the same brand carries several sites’ worth of content: a molecule approved for plaque psoriasis, psoriatic arthritis and Crohn’s disease has three indications, three sets of efficacy data, three audiences, and three separate approvals that arrived at different times. Anything said about a use the label does not cover is off-label, and saying it in marketing is the thing the entire review apparatus exists to prevent.

Biopharma

What the drug is approved for. The narrowest and most load-bearing word in pharmaceutical marketing.

Avoid: writing a headline that works across indications because it tested well. Each indication's claims are approved separately, and a sentence that is accurate for one can be off-label for another — which is a regulatory finding, not a copy note.

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