Clozapine guidance finalized
Executive Summary
Bioequivalence studies for generic clozapine (Novartis' Clozaril) should only be conducted with patients who are already "stable" on clozapine dose, FDA's final guidance says. Initial version updated 1996 guidance to say clozapine bioequivalence should not be tested in healthy subjects (1"The Pink Sheet" Jan. 5, 2004, In Brief)...