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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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References in periodicals archive ?
05 (ANI): There have been concerns about off-label drug use causing vision loss in the patients.
Doctors have used hydroxychloroquine as an off-label alternative.
More recently, the analyst notes, questions have been raised as to whether Cosmo's rifamycin could pose a threat to Xifaxan, either in the near term from off-label prescribing for irritable bowel syndrome with diarrhea, or longer term if eventually approved for IBS-D.
AN OFF-LABEL drug thought to be commonly prescribed by doctors to treat osteoarthritis of the hand when conventional medication has failed is ineffective, say researchers.
Focus: RICO Claims Plaintiffs contend that Payors bear the principal costs of off-label promotions, because they pay for most of the cost of the drugs, but comparing the patients health costs (and out- of-pocket co-pays) with the Payors costs may be difficult.
Off-label prescription, by some estimates, accounts for 25 percent of all prescriptions, (Leibman 2003) but can be significantly higher for certain conditions.
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.
The risky, off-label use of glucose monitors with critically ill patients is under close scrutiny by the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), with virtually every hospital reevaluating its options for glucose testing.
James Hoyer client Peggy Ryan, whistleblower in the off-label marketing case against a pharmaceutical company, was also named Whistleblower of the Year.
In this Article, I consider the FDA's restrictions on off-label promotional speech by pharmaceutical companies.
Off-label prescribing of drugs is common and very likely to cause adverse events, particularly when no strong scientific evidence supports the off-label use, according to a report.