VERSACLOZ

FDA-2025-P-4282

Gilbert Honigfeld filed this petition under 21 CFR 10.30 on September 23, 2025, requesting that the FDA add a third indication to clozapine labeling for the reduction in risk of recurrent aggressive behavior in individuals with serious mental illness. Honigfeld, who was involved in clozapine's origi

FDA-2020-P-1073

David Behar, M.D., a psychiatrist, submitted this citizen petition on March 9, 2020, requesting that the Commissioner decommission the clozapine REMS program, remove the requirement for healthcare provider certification to prescribe clozapine, and modify the package insert to defer mandatory blood m

FDA-2014-P-1622

Genesee Health System filed this citizen petition pursuant to 21 CFR 10.30 requesting that the FDA amend the Clozapine Risk Evaluation and Mitigation Strategy (REMS) to accommodate benign ethnic neutropenia by adjusting baseline white blood cell count thresholds and monitoring parameters for patient

FDA-2010-P-0574

Beckloff Associates, Inc., as agent for Azur Pharma International III Ltd., filed a citizen petition on November 2, 2010, pursuant to Section 505(j)(2)(C) requesting that the FDA designate FazaClo (Clozapine) Orally Disintegrating 200 mg tablet as the Reference Listed Drug for clozapine orally disin

FDA-2010-P-0546

Beckloff Associates, on behalf of Azur Pharma International III Ltd., filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate FazaClo (Clozapine) Orally Disintegrating 200 mg tablet as the Reference Listed Drug for cl

FDA-2007-P-0188

Beckloff Associates, Inc. filed this citizen petition on December 26, 2007, pursuant to 21 CFR 10.30, requesting that the FDA Commissioner require both fasted and fed bioequivalence studies as part of the bioequivalence demonstration for clozapine orally disintegrating tablets (ODT), 100 mg, in ANDA