Off-label application

Off-label application

The use of a prescription medication to treat conditions outside the indications approved by the Food and Drug Administration (FDA).
References in periodicals archive ?
This demands expert testimony about off-label use, a topic that the PDR cannot address because neither the drug company, nor the FDA, investigated, tested or reviewed the off-label application.
Interventional cardiologists used an approved device for an off-label application in 63 percent of the patients.
Prevention of bone loss in breast cancer patients treated with hormonal therapy is at present an off-label application for zoledronic acid.
It resolves allegations that Novartis and Chiron Corporation, which Novartis acquired in 2006, allowed false claims to be submitted to federal healthcare programmes for some off-label applications of TOBI.
Even though Cytotec's fortunes as a gastrointestinal drug have waned and off-label applications drive its current sales, its manufacturer, Pfizer, demurs when asked about its use in abortions.