Indication
The specific use of a drug as authorised by a regulator.
Definition
An indication is the specific medical condition, patient population, disease stage, or line of therapy for which a drug has been authorised by a regulator. The FDA label's Indications and Usage section is binding for promotion. Many drugs have multiple indications added through supplemental NDAs/BLAs over time (e.g. Keytruda has 35+ FDA-approved indications).
See also
- NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
- Off-label — Prescribing a drug for a use not specifically approved by the FDA.