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Aegerion agrees to plead guilty and enter into a
consent decree with FDA
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Today, Aegerion
Pharmaceuticals Inc. agreed to plead guilty in the United States District Court
for the District of Massachusetts to two misdemeanor counts of violating the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) involving the introduction of misbranded Juxtapid (lomitapide) into
interstate commerce. In connection with this agreement, the
criminal information filed today charged that Juxtapid was misbranded because
Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation
and Mitigation Strategy (REMS) program and because the drug’s labeling lacked adequate
directions for all of Juxtapid’s intended uses. This agreement resolves a
criminal investigation in which the U.S. Food and Drug Administration’s Office
of Criminal Investigations played an important role. Continue reading...
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