Off-label

Prescribing a drug for a use not specifically approved by the FDA.

Definition

Off-label prescribing — using an FDA-approved drug for an indication, dose, population, or route not in the approved label — is legal in US clinical practice but commercial promotion of off-label use is restricted. Common in oncology (≥30% of cancer prescriptions off-label), psychiatry, and paediatrics. Different rules apply for promotion vs. educational discussion.

See also

• Indication — The specific use of a drug as authorised by a regulator.

Other commercial terms

• Biosimilar
• Generic drug
• QALY
• NICE TA
• ICER (cost)
• WAC