CLOZARIL

FDA-2025-P-4282 · 42 docket documents

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 · 5 docket documents

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 · 13 docket documents

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 · 7 docket documents

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 · 4 docket documents

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-2009-P-0046 · 3 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Clozapine Oral Suspension, 50 mg/mL, suitable for consideration in an ANDA under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with Clozaril Tablets 100 mg as the re

FDA-2008-P-0289 · 3 docket documents

Lachman Consultant Services, Inc., filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Clozapine Tablets, 150 mg, suitable for consideration in an abbreviated new drug application, with Clozaril (clozapine tablets) 100 mg, N

FDA-2007-P-0188 · 6 docket documents

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