off-label use

(redirected from Offlabel use)

off-label use

Unlabeled indication, unlabeled use Pharmacology The use of a drug–eg, tretinoin, an analog of vitamin A or medical device–eg, injectable collagen, to treat a condition for which it has not received approval by a regulatory agency–eg, the FDA; OLU is common in chemotherapy of difficult-to-treat cancers, for which there is no agreement on standardized therapy

Off-label use

A drug that is prescribed for uses, periods of time, or at dosages that are not FDA-approved.
References in periodicals archive ?
Covert promotion of pharmaceuticals is an important public health issue because it can contribute to unnecessary overuse of certain drugs or lead to their offlabel use without sufficient evidence of efficacy, the Canadian journal said in an accompanying editorial.
While the FDA does not regulate offlabel use--leaving it up to providers' clinical judgment to prescribe medicines appropriately--it does prohibit pharmaceutical companies from marketing drugs for unapproved purposes such as offlabel use.
Although treating an overactive bladder or sphincter with Botox is an offlabel use of the product, it's still possible to get paid for it.
Governments in Europe and Japan have acknowledged a valuable role for appropriate offlabel use of cancer therapies, but tough reimbursement restrictions severely limit physicians' prescribing freedoms.
Department of Justice negotiated a settlement agreement in which Allergan pled guilty to criminal misbranding charges related to the firm's promotion of Botox for offlabel uses.