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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 ...
Quetiapine (Seroquel) 25 mg tablets, next to US one-cent coin for comparison Seroquel XR 150 mg tablet box Quetiapine is primarily used to treat schizophrenia or bipolar disorder. [ 19 ] Quetiapine targets both positive and negative symptoms of schizophrenia.
Seroquel: AstraZeneca [15] $520,000,000 $520 million (civil only) Off-label promotion/kickbacks False Claims Act 2007 12 11 Abilify/Serzone: Bristol-Myers Squibb [16] $540,000,000 $515 million ($25 million in civil disgorgement) Off-label promotion/ kickbacks/Medicare fraud False Claims Act/FDCA 2016 14 (tie) 12 EpiPen (epinephrine) Mylan [17 ...
Still, the suit focused on diabetes, and the complaint Sheller wrote was a hodgepodge of weak claims, in large part because the boy had also taken the Risperdal competitor drug Seroquel. Its manufacturer, AstraZeneca, was also named as a defendant, as was the boy’s doctor, who was accused of malpractice.
Seroquel: False Claims Act 2007 Bristol-Myers Squibb [18] $515 million Off-label promotion, kickbacks, Medicare fraud Abilify, Serzone: False Claims Act, FDCA 2002 Schering-Plough [19] $500 million Poor manufacturing practices Claritin: FDA Current Good Manufacturing Practices: 2006 Mylan [20] $465 million Misclassification under the Medicaid ...
(Reuters) -A federal judge on Monday dismissed a lawsuit by a major pharmaceutical industry trade association challenging a new program that allows Medicare to negotiate prices with drug companies ...
In April 2010, AstraZeneca settled a qui tam lawsuit brought by Stefan P. Kruszewski for US$520 million to settle allegations that the company defrauded Medicare, Medicaid, and other government-funded health care programs in connection with its marketing and promotional practices for the blockbuster atypical antipsychotic, Seroquel. According ...
Hemp XR said in its response to the lawsuit that Howard was instructed by employees to not use the product and drive, as stated on the packaging. Court documents from Hemp XR say the employees ...