Definition

Off-label use

Prescribing a drug for a use the FDA has not formally approved, a common and legal practice.

Off-label use means a clinician prescribes an approved drug for a condition, dose, or population outside its FDA-approved labeling. It is legal and common when supported by evidence and clinical judgment. For GLP-1s, using the diabetes brands (Ozempic, Mounjaro) for weight loss is off-label, while the weight-management brands (Wegovy, Zepbound) are on-label for that purpose. Off-label status can affect insurance coverage.

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