off-label use

• FDA

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
• Uncategorized

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…

• FDA

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…

• FDA

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…