Federal Register Notice: FDA is making available a guidance for industry entitled Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing. The guidance was originally published 11/96, but because of potentially significant adverse effects seen in healthy subjects who had not previously used clozapine, FDA proposed a revision to the guidance in a 12/03 draft. The final guidance includes a change in the recommended patient population and other minor changes. To download the guidance, click here. To view this notice, click here.
