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Glossary · Tier 1

Indication

Also known as: approved use, indications and usage, labeled indication

Verified from eCFR 21 CFR 201.57 on 06-02-2026
Quick answer

In FDA drug labeling, the indication identifies what a drug is approved to treat, prevent, mitigate, cure, or diagnose, or what symptoms it is approved to relieve. It appears in the Indications and Usage section of the prescribing information and defines the scope of the approved medical use. The verbatim regulatory text from the U.S. Office of the Federal Register follows.

MedivaScan summary. The authoritative source quote follows below.

eCFR 21 CFR 201.57 definition

1 Indications and usage. This section must state that the drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.

U.S. Office of the Federal RegisterView on source ›Verbatim quote. Last verified 06-02-2026.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.