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Allergan Loses Another Battle, But War To Block Restasis Generics Continues

 
• By Brenda Sandburg

US FDA rejects Allergan's third citizen petition seeking to require comparative clinical trials of generic versions of its dry eye medicine; company appeals patent invalidity ruling and PTAB admonishes Mohawk Tribe for its actions in IPR proceeding.

Eye

Allergan PLC has been tenacious in trying to get the US FDA to impose more stringent standards for approval of generic versions of its dry eye medicine Restasis (cyclosporine). But the agency 's rejection of its third citizen petition shows this strategy is unlikely to block generic competition.

The three petitions – submitted in February 2014, December 2014 and August 2017 – oppose FDA's decision to allow generic manufacturers to rely on in vitro testing to show bioequivalence of their products to Restasis

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