Guidance: Unsupported Pediatric Uses Must Be Called Out in Labeling

When pediatric use of a drug or biologic is not supported by available data, or has not been established as safe and effective, the drugmaker must include a statement to that effect in the Pediatric Use subsection of labeling, a draft guidance says. In such a case, information on the unapproved use should only appear in the Pediatric Use subsection to avoid giving the impression the drug has an approved pediatric use.
Washington Drug Letter