off-label use


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off-label use

Unlabeled indication, unlabeled use Pharmacology The use of a drug–eg, tretinoin, an analog of vitamin A or medical device–eg, injectable collagen, to treat a condition for which it has not received approval by a regulatory agency–eg, the FDA; OLU is common in chemotherapy of difficult-to-treat cancers, for which there is no agreement on standardized therapy
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.

Off-label use

A drug that is prescribed for uses, periods of time, or at dosages that are not FDA-approved.
Gale Encyclopedia of Medicine. Copyright 2008 The Gale Group, Inc. All rights reserved.
References in periodicals archive ?
Even if a drug is legal and prescribing it for off-label use is legal, it is "misbranding" for the drug maker to share accurate information about the off-label use.
"Off-Label Use of Drugs and Medical Devices: A Review of Policy Implications." Clinical Pharmacology and Therapeutics, 91(5): 920-25.
Given these costs, we estimate that in 2008 $6.0 billion was expended on off-label use of antipsychotic medications, of which $5.4 billion was for uses with uncertain evidence.
All improper use is, by definition, off-label, but not all off-label use is improper.
The FDA would still have authority to investigate and enforce civil and criminal remedies against untruthful and misleading commercial "speech." But a loss on appeal would significantly reduce the number of billion-dollar criminal and civil settlements by the Justice Department against pharmaceutical companies who honestly promote off-label uses of their drugs.
Parallel research determines an off-label use for drug X in treating condition B, but the market for condition B is much more competitive.
A growing body of evidence supports the off-label use of clozapine for patients with bipolar disorder as well.
According to the First Amendment critique of the FDA's off-label promotion regulations, if the FDA is concerned about off-label use of a prescription drug, the agency should regulate off-label use itself, thereby limiting off-label prescribing without infringing on freedom of speech.
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange.
(122) With each concluded litigation or settlement, another suit is brought against another pharmaceutical manufacturer alleging similar FCA issues and the company's off-label marketing scheme to produce greater sales based on off-label use. (123) In United States ex rel.