The efficacy claims that are approved by the relevant government health agency for the medicine on the basis of the Core (Pivotal) Registration Studies. The indication is contained in the product label, also called prescribing information. The indications for a product may (and often do) differ by geography and country.

The defined disease or clinical condition which an investigational product may be given after regulatory approval.

The disease and patient population that a drug is approved to treat.

The use for which a drug or therapy is intended in vitro Within a glass, observable in a test tube, in an artificial environment. in vivo Within the living body.

A disease target for a drug.

The disease a drug is approved by the U.S. Food and Drug Administration (FDA) to treat. For example: Lexapro is indicated for the treatment of depression and GAD. Close Window

purpose of a drug

The disease or condition a drug is designed to treat is referred to as its indication. A single drug may have multiple indications.

a specific use (indicated use) for which a drug has been approved by the FDA

The uses for which a specific drug is approved by the U.S. Food and Drug Administration (FDA).

Purpose for which a drug is prescribed. The approved indications appear on the product monograph included with the manufacturer's drug packaging.