Definition:
Off-label is the term used when a drug is prescribed for a use not approved by the Food and Drug Administration. It is legal for a doctor to prescribe a medication for other uses than those the FDA has approved. However, it is not legal for the manufacturer to market and promote a drug for any use except what has been approved by the FDA.
Off-label is the term used when a drug is prescribed for a use not approved by the Food and Drug Administration. It is legal for a doctor to prescribe a medication for other uses than those the FDA has approved. However, it is not legal for the manufacturer to market and promote a drug for any use except what has been approved by the FDA.
Examples:
Many drugs now approved for use in treating bipolar disorder were prescribed off-label to patients with BP for years before they received FDA approval.
