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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.


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.
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These drug classes are notable for their demonstrated efficacy in reducing body weight, and as such are also being used off-label in the treatment of obesity.
sales executive Fhtrick Fabian have become part of a growing crusade challenging the FDA's restrictions on the language used in off-label promotions.
To calculate the market size, the report considers revenue generated from sales of various drugs used in the treatment of opioid-induced constipation, which includes branded drugs, off-label products, and OTC drugs.
For us, the off-label use of antimuscarinics is common practice.
In the January 2013 edition of the Archives, I described, in "Food and Drug Administration Approval of Laboratory Tests," (1) the US Food and Drug Administration's (FDA's) off-label drug conundrum, and how it might apply (or chaos it might cause) were the FDA to begin approving laboratory tests.
Brad Weeks's medical license for three years, claiming that, because he prescribed low doses of human growth hormone (HGH) on an off-label basis to three patients between 2006 and 2009, he is a threat to the public health and safety.
patients nationwide have been implanted with Infuse during procedures involving off-label use, including posterior lumbar interbody fusion.
Scott Jones, Partner with Locke Lord LLP will speak at the KC's webcast entitled: “FDA's Off-Label Information: A 2013 Update Live Webcast” on April 16, 2013 from 12:00 PM to 2:00 PM ET.
The Food and Drug Administration (FDA) has been aggressive in pursuing drug companies and their sales personnel that promoted drugs for off-label uses, or uses that the FDA has not approved.
Caronia case and ruled that a pharmaceutical sales rep's conversations with a physician about the off-label use of a drug was protected by the First Amendment.
2) Medical professionals often consider off-label use to be state of the art treatment because medical discoveries regarding new uses for existing drugs typically outpace the FDA's relatively slow regulatory process.
FDA's recent draft guidelines for companies on responding to requests for off-label information, were updated specifically to address requests made through social media.