Tetrabenazine

Overview

A drug formerly used as an antipsychotic but now used primarily in the symptomatic treatment of various hyperkinetic disorders. It is a monoamine depletor and used as symptomatic treatment of chorea associated with Huntington's disease. FDA approved on August 15, 2008.

Indication

Treatment of hyperkinetic movement disorders like chorea in Huntington's disease, hemiballismus, senile chorea, Tourette syndrome and other tic disorders, and tardive dyskinesia

Associated Conditions

Gilles de la Tourette's Syndrome
Hemiballismus
Huntington's Disease (HD)
Tardive Dyskinesia (TD)
Senile chorea

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions	2018/10/11	NCT03702855	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions	2018/10/04	NCT03696329	Phase 1	Completed	Dr. Reddy's Laboratories Limited
A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)	2015/07/28	NCT02509793	Phase 4	Recruiting	William Ondo, MD
Effect of Tetrabenazine on Stroop Interference in HD	2013/04/18	NCT01834911	Phase 4	Completed	New York Medical College
Xenazine in Late Dyskinetic Syndrome With Neuroleptics	2012/03/02	NCT01543321	Phase 3	Completed	Centre Hospitalier Universitaire, Amiens
A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette's Syndrome	2010/05/28	NCT01133353	Phase 2	Withdrawn	Bausch Health Americas, Inc.
Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements	2008/03/24	NCT00642057	N/A	NO_LONGER_AVAILABLE	Joseph Jankovic
Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride	2008/03/11	NCT00632645	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris
Tetrabenazine for Partial Responders	2006/08/10	NCT00362804	Not Applicable	Completed	Centre for Addiction and Mental Health
Efficacy and Safety of Tetrabenazine in Chorea	2005/09/22	NCT00219804	Phase 3	Completed	Prestwick Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tetrabenazine	Precision Dose Inc.	68094-805	ORAL	25 mg in 1 1	8/31/2023
TETRABENAZINE	Bionpharma Inc.	69452-117	ORAL	12.5 mg in 1 1	1/24/2024
Tetrabenazine	Apotex Corp.	60505-3883	ORAL	25 mg in 1 1	12/5/2023
Tetrabenazine	Camber Pharmaceuticals, Inc.	31722-822	ORAL	25 mg in 1 1	1/16/2018
tetrabenazine	Slate Run Pharmaceuticals, LLC	70436-102	ORAL	25 mg in 1 1	10/22/2020
Tetrabenazine	Camber Pharmaceuticals, Inc.	31722-821	ORAL	12.5 mg in 1 1	1/16/2018
TETRABENAZINE	TAGI Pharma, Inc.	51224-425	ORAL	12.5 mg in 1 1	1/30/2019
Tetrabenazine	Sun Pharmaceutical Industries, Inc.	47335-179	ORAL	25 mg in 1 1	8/10/2023
Tetrabenazine	Apotex Corp.	60505-3882	ORAL	12.5 mg in 1 1	12/5/2023
Tetrabenazine	Golden State Medical Supply, Inc.	51407-480	ORAL	12.5 mg in 1 1	12/29/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
iNova TETRABENAZINE 25mg tablet bottle	13695	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/23/1991
TETRABENAZINE SUN tetrabenazine 25 mg tablet bottle	381235	Sun Pharma ANZ Pty Ltd	Medicine	A	11/28/2022
TETRABENAZINE RBX tetrabenazine 25 mg tablet bottle	381236	Sun Pharma ANZ Pty Ltd	Medicine	A	11/28/2022
TETRABENAZINE RAN tetrabenazine 25 mg tablet bottle	381234	Sun Pharma ANZ Pty Ltd	Medicine	A	11/28/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-TETRABENAZINE	Pharmascience Inc	02402424	Tablet - Oral	25 MG	2/26/2013
TETRABENAZINE TABLETS	Sterimax Inc	02410338	Tablet - Oral	25 MG	8/29/2013
APO-TETRABENAZINE	Apotex Inc	02407590	Tablet - Oral	25 MG	11/1/2013
NITOMAN	bausch health, canada inc.	02199270	Tablet - Oral	25 MG	12/9/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TETRABENAZINA ARISTO 25 MG COMPRIMIDOS EFG	Aristo Pharma Gmbh	84164	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
TETRABENAZINA SUN 25 MG COMPRIMIDOS EFG	Sun Pharmaceutical Industries (Europe) B.V.	82080	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
TETMODIS 25 mg COMPRIMIDOS EFG	Aop Orphan Pharmaceuticals Gmbh	72730	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NITOMAN 25 mg COMPRIMIDOS	Bausch Health Ireland Limited	70142	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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