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off-label use

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…

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…

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…

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…