Clozapine ANDA studies to provide for I.V. access for six hours in case of adverse events -- FDA letter.
Executive Summary
CLOZAPINE BIOEQUIVALENCE STUDIES -- INTRAVENOUS ACCESS IS MANDATORY FOR SIX HOURS after dosing in case of adverse events in study subjects, according to an April 22 letter sent to all NDA and ANDA applicants. The guidance for bioequivalence studies involving Sandoz' Clozaril (clozapine) previously stated that "intravenous access should be considered for at least six hours after dosing," whereas the new guidance states that "intravenous access should be mandatory."