off-label indication

off-la·bel in·di·ca·tion

(awf-lā'bĕl in'di-kā'shŭn)
Use of a medication for a purpose other than that approved by the U.S. Food and Drug Administration.

off-la·bel in·di·ca·tion

(awf-lā'bĕl in'di-kā'shŭn)
Use of a medication for a clinical purpose other than that approved by the U.S. Food and Drug Administration.
References in periodicals archive ?
Recently, the indications for cochlear implantation were expanded to include patients with SSD, although this is still considered an off-label indication by the federal Food and Drug Administration.
General Accounting Office (GAO, now known as the Government Accountability Office) found that one-third of the drugs prescribed for the treatment of cancer were off-label, and that more than half of all cancer patients received at least one drug for an off-label indication.
There are few case reports documenting the use of recombinant activated factor VIIa for this type of off-label indication.
These sources, however, are limited by publication lag, and they may not adequately address whether an off-label indication is a sufficiently effective treatment (Laetz and Silberman, 1991; McKenna, 1990).
Grimes cautioned that vitiligo is an off-label indication for tacrolimus, pointing out that very long-term studies have not yet been conducted.
Using magnetic resonance angiography for detection of pulmonary emboli is an off-label indication, but "we're heading in this direction clinically--there is no magic behind this anymore.
The use of MYOBLOC may be considered a medically necessary off-label indication for spasticity caused by stroke or brain injury," as noted on the CMS website.
With Provigil, because a high percentage of sales of the drug are in off-label indications, the company could be negatively impacted by any clinical trial that shows disappointing results for Provigil in an off-label indication, failure of physicians to prescribe Provigil off-label, failure to obtain label expansion in additional indications, and failure of insurance companies and third-party payers to reimburse the drug.
In this context, she has handled more than 500 opinion matters, including issues relating to FDA exclusivity, new chemical entities, importation of active ingredients, synthetic intermediates, polymorphs, approved and off-label indications, finished formulations/compositions and drug products.
This is an opportunity to document off-label indications and to link to the evidence for off-label uses," said Dr.
The app delivers actionable recommendations to take users beyond the drug package insert to find off-label indications, dosing recommendations, therapeutic class, administration, monitoring, toxicology, clinical teaching, and more, giving customers access to the highest quality evidence available.