Al­ler­gan caps a bad day with news the FDA has kicked back a sup­ple­men­tal ap­pli­ca­tion for cariprazine

Al­ler­gan $AGN is not hav­ing a good day to­day.

Af­ter post­ing some mixed, weak ex­tend­ed year-two da­ta on its NASH drug, the com­pa­ny end­ed the day with a short note that the FDA had is­sued a refuse-to-file let­ter on its sup­ple­men­tal ap­pli­ca­tion for cariprazine as a new ther­a­py for neg­a­tive symp­toms as­so­ci­at­ed with schiz­o­phre­nia.

The drug was al­ready ap­proved for schiz­o­phre­nia and the acute treat­ment of adult pa­tients with man­ic or mixed episodes as­so­ci­at­ed with bipo­lar I dis­or­der. Ac­cord­ing to Al­ler­gan, the FDA told them that their ap­pli­ca­tion “was not suf­fi­cient­ly com­plete to per­mit a sub­stan­tive re­view.”

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