Questions and Issues
November 4, 2002
PDAC
Clozarilâ (clozapine, Novartis Pharmaceuticals Corporation)
Issues for which FDA would like committee discussion and feedback:
Question for which FDA would like a committee vote:
Do the data from the InterSePT Study, along with other data provided in this NDA supplement, provide a sufficient basis for a new claim involving suicidality in schizophrenia and schizoaffective disorder [Note: Part of the challenge to the committee is to articulate what the new claim should be.]?