Ot­su­ka, Lund­beck eye Alzheimer's in­di­ca­tion in FDA ad­comm for Rex­ul­ti la­bel ex­pan­sion

Ot­su­ka and Lund­beck’s br­ex­pipra­zole is get­ting a joint FDA ad­comm to po­ten­tial­ly ex­pand the men­tal health drug’s la­bel for the treat­ment of ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia.

The April 14 meet­ing in­cludes the Psy­chophar­ma­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee and the Pe­riph­er­al and Cen­tral Ner­vous Sys­tem Drugs Ad­vi­so­ry Com­mit­tee.

Br­ex­pipra­zole is mar­ket­ed as Rex­ul­ti for its ap­proved in­di­ca­tions in schiz­o­phre­nia in adults and chil­dren ages 13 and old­er, as well as for ma­jor de­pres­sive dis­or­der in adults who are tak­ing oth­er an­ti­de­pres­sant med­ica­tions.

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