FDA ac­cepts one, de­lays an­oth­er; Da­ta, deals and dol­lars for slate of biotechs

The schiz­o­phre­nia and ma­jor de­pres­sive dis­or­der drug out of Ot­su­ka Phar­ma­ceu­ti­cal and Lund­beck is now un­der pri­or­i­ty re­view at the FDA for an­oth­er in­di­ca­tion.

The drug de­vel­op­ers said the reg­u­la­tor will de­cide whether to ex­pand the la­bel of br­ex­pipra­zole, mar­ket­ed as Rex­ul­ti for ap­proved in­di­ca­tions, to in­clude ag­i­ta­tion as­so­ci­at­ed with Alzheimer’s de­men­tia by May 10. The com­pa­nies said the FDA in­di­cat­ed it plans to con­vene an ex­pert pan­el to ad­vise on the ap­pli­ca­tion.

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