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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 ...
In March 2020, then US President Donald Trump promoted the use of chloroquine and hydroxychloroquine, two related anti-malarial drugs, for treating COVID-19. The FDA later clarified that it has not approved any therapeutics or drugs to treat COVID-19, but that studies were underway to see if chloroquine could be effective in treatment of COVID-19.
Ketogenic diet – a severe carbohydrate-restricted diet that induces ketosis and is used for the treatment of drug-resistant epilepsy. Advocates assume the diet avoids "fuelling" cancer tumours and say the diet can be used as a substitute for convention treatment, but their claims are not supported by medical evidence. [23]
The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1 products, including one that claims to be approved by the FDA. US FDA warns online vendors ...
The U.S. Food and Drug Administration (FDA) on Tuesday published letters warning two online vendors to stop selling unapproved versions of semaglutide and tirzepatide, the active ingredients in ...
“FDA has rightly and repeatedly expressed concerns with unapproved GLP-1 drugs used for weight loss, and that such drugs are risky for patients, as unapproved versions do not undergo FDA’s ...
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.
This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market.