Novartis Clozaril suicide indication
This article was originally published in Pharmaceutical Approvals Monthly
Novartis' Clozaril (clozapine) clears FDA Dec. 18 for reduction of suicidal behavior in schizophrenic and schizoaffective patients. The Dec. 18 approval significantly broadens Clozaril's patient population; the atypical antipsychotic was previously indicated for second-line use in severely ill schizophrenics. The indication is based on the 980-patient International Suicide Prevention Trial (InterSePT), which found Clozaril reduced the risk of suicide attempts by 25% compared to Lilly's Zyprexa (olanzapine). Novartis gains 36 months of exclusivity for the suicide indication; several generic versions of clozapine are available, but market erosion has been limited by required monitoring for agranulocytosi
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