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(ôf′lā′bəl, ŏf′-)
Of or relating to a drug prescribed to treat a condition for which it has not been approved by the Food and Drug Administration.
American Heritage® Dictionary of the English Language, Fifth Edition. Copyright © 2016 by Houghton Mifflin Harcourt Publishing Company. Published by Houghton Mifflin Harcourt Publishing Company. All rights reserved.


pertaining to or designating a drug prescribed for a particular indication even though the drug has not yet received approval from the Food and Drug Administration for that disease, condition, or symptom.
Random House Kernerman Webster's College Dictionary, © 2010 K Dictionaries Ltd. Copyright 2005, 1997, 1991 by Random House, Inc. All rights reserved.
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Caronia, the Second Circuit Court of Appeals overturned the criminal conviction of a pharmaceutical sales representative who was punished for promoting off-label use of the drug Xyrem.
The first, overturning a decades-old prohibition of the off-label detailing of drugs, surprisingly was decided against the government.
([1]) The prescribing of drugs for nonFood Drug Administration (FDA) approved uses is called as "off-label prescribing." [2] Off-label use also includes the use of pharmaceutical drugs in unapproved age group, dosage, or form of administration.
Because Part D lacks adequate oversight for off-label drug usage, pharmaceutical companies obtain windfall profits for drugs that have not been proven effective for off-label conditions.
If approved, ONS-5010 has potential to mitigate risks associated with off-label use of Avastin or other drugs.
Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.
(8-10) Other articles (11-13) called for a moratorium on the off-label use of glucose meters following sentinel events in at least two New York State hospitals in early 2014, which required greater scrutiny of the use of these devices in hospitals.
Q Is it safe to take a drug "off-label?" My doctor recommended I do so.
men ages 50 and older (average age 71.2) from 2007 to 2016 and compared testosterone prescriptions written for on-label and off-label use.
Klein and her colleagues conducted a study aimed at identifying the off-label medications being prescribed to potentiate sleep in children with ADHD, and the characteristics of the children and their prescribers.
Yet drug- and device-makers have continued to push for more and more freedom to market products "off-label," promoting products to groups and for uses that were never approved--maybe never even tested at all!