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Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

 
• By Brenda Sandburg

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.

Courthouse Pillars & Stairs

The pharma industry has had a busy week in court. Perhaps most significantly, a US district court rejected Teva Pharmaceutical Industries Ltd.'s claims that it has the right to 180-day exclusivity for its generic version of Restasis (cyclosporine), noting that FDA has yet to grant even tentative approval to a pending ANDA and it is unknown whether Teva will clear forfeiture hurdles.

In a Feb. 26 order, the US District Court for the District of Columbia granted FDA and intervenor generic...

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