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FDA
Food and Drug Administration
- A U.S. jury found Takeda Pharmaceutical liable for $885 million in damages for delaying generic competition of constipation drug Amitiza through an anticompetitive scheme. - The verdict marks the first time a pharmaceutical company has been found liable by a jury in class action litigation over pay-for-delay agreements since the 2013 Supreme Court ruling. - Under federal antitrust law, the $885 million award could be automatically tripled to several billion dollars, representing a significant financial penalty for the Japanese drugmaker. - The case centered on a 2014 settlement where Takeda allegedly paid Par Pharmaceutical $210 million to delay launching generic lubiprostone until January 2021, postponing competition by six years.