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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Other off-label uses include cancer pain, hot sweats, certain psychiatric disorders, nicotine dependence, opioid withdrawal, migraine headaches, and restless leg syndrome. Colchicine (Colcrys) for pericarditis: colchicine is indicated for the treatment and prevention of gout, though it is also generally considered first-line treatment for acute ...
Levetiracetam, sold under the brand name Keppra among others, is a novel antiepileptic drug [7] used to treat epilepsy. [8] It is used for partial-onset , myoclonic , or tonic–clonic seizures, [ 7 ] and is taken either by mouth as an immediate or extended release formulation or by injection into a vein .
While estimates vary, some studies suggest that 1 in 5 prescriptions of common medications involves an off-label use. Skip to main content. 24/7 Help. For premium support please call: 800-290 ...
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
When a medication is used off-label, it means the drug is approved by the U.S. Food and Drug Administration (FDA) for a particular use, but a healthcare provider prescribes it to treat something else.
The medication is produced by the pet drug firm Zoetis and was approved by the FDA last year. The dog medication Librela is likely sickening and killing dogs, the FDA warned. Ermolaev Alexandr ...
Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses").