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Examples
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Any approved use is on-label, while any use not listed on the insert is considered off-label.
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Before they can be sold in the U.S., every new medicine must be certified by the FDA as safe and effective for a specific, or "on-label," use.
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Last September the FDA ordered Allergan to send detailed safety updates to physicians who prescribe Botox for both on-label and off-label indications.
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Before a drug can be sold in the U.S., it must be certified by the FDA as safe and effective for a specific, or "on-label," use; but traditionally, once it has been approved, physicians may legally prescribe it for any other purpose.
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Last September, using its REMS authority, the FDA ordered Allergan to send detailed safety updates to physicians who prescribe Botox for both on-label and off-label indications.
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ImClone said it "only promotes the use of Erbitux for on-label, FDA-approved indications" and "it is not our practice to comment on compendia listings."
Medicare Shift on 'Off-Label' Drugs Raises Issue of Conflicts 2009
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These are all off-label, and you'll find thousands of other on-label chemicals used in foods, including the main ingredient in anti-freeze.
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As matters now stand, no off-label use is possible for any drug that has not been certified for some particular on-label use.
Cancer Patients Deserve Faster Access to Life-Saving Drugs 2009
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He also learned that they received incentives regardless of whether treatment was on-label or off-label.
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Zyprexa is not approve for any on-label indication for children but even if it was, schizophrenia is extremely rare in children at about 1 in 40,000 under the age of 18, according to the National Institute of Mental Health, and psychiatrists do not even agree on what criteria should be used to diagnose children with bipolar disorder.
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