Tag Archive: off-label use

Nov 12

J&J Company Pleads Guilty to Misbranding for Off-Label Marketing

On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), arising from its off-label marketing of the drug. …

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Sep 17

FDA Approves Botox Cosmetic for New Intended Use

On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered …

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Dec 10

Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of the Federal Food, Drug and Cosmetic Act (“FDCA”). The Defendant-Appellant in the case, Alfred Caronia, …

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Jul 02

GlaxoSmithKline to Pay $3 Billion in Settlement with Government

On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be pleading guilty to marketing two of its drugs, Paxil and Wellbutrin, for unapproved uses and …

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