FTC 'Ready' To Go After Abusive Citizen Petitions; Allergan Wants 'Substantive' FDA Responses
US FDA draft guidance on citizen petitions elicits comments of support, including call to exclude brand manufacturer petitions except in urgent situations.
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US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.
New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.
Court tosses FTC complaint alleging Shire used the citizen petition process to maintain a monopoly on Vancocin, says agency did not show company was 'about to violate' the law.