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Amid Patent Battle, FDA Approves First Generics Of Gilenya For MS

By Beth Wang / December 5, 2019 at 6:39 PM
FDA on Thursday (Dec. 5) approved three first-generic versions of Novartis’ multiple sclerosis drug Gilenya (fingolimod), which is currently the subject of ongoing patent litigation that Novartis brought against myriad companies, including the sponsors of the three generics. Gilenya, which was first approved in 2010, is a once-a-day pill used for the treatment of relapsing forms of MS in adults and children ages 10 years and older. The three generic versions are only indicated for adults. In the agency’s announcement...


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