DOJ Sues Drugmaker Over Unapproved Misbranded Drugs

Law360, New York (June 20, 2013, 6:53 PM EDT) -- The U.S. Department of Justice has hit Sage Pharmaceuticals Inc. with a misbranding suit in Louisiana federal court accusing the company of unlawfully manufacturing and selling several drugs without regulatory approval, it announced Thursday.

Shreveport, La.-based Sage had made and sold at least eight drugs without FDA approval, despite knowing its actions were unlawful, in violation of the Food, Drug and Cosmetic Act, according to the complaint, filed on behalf of the U.S. Food and Drug Administration.

“As demonstrated by the results of FDA’s most recent...
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