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 |
|---|---|---|---|---|---|
2018/10/11 | Phase 1 | Completed | |||
2018/10/04 | Phase 1 | Completed | |||
2015/07/28 | Phase 4 | Recruiting | William Ondo, MD | ||
2013/04/18 | Phase 4 | Completed | |||
2012/03/02 | Phase 3 | Completed | |||
2010/05/28 | Phase 2 | Withdrawn | |||
2008/03/24 | N/A | NO_LONGER_AVAILABLE | Joseph Jankovic | ||
2008/03/11 | Phase 3 | Completed | |||
2006/08/10 | Not Applicable | Completed | |||
2005/09/22 | Phase 3 | Completed | Prestwick Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Precision Dose Inc. | 68094-805 | ORAL | 25 mg in 1 1 | 8/31/2023 | |
| Bionpharma Inc. | 69452-117 | ORAL | 12.5 mg in 1 1 | 1/24/2024 | |
| Apotex Corp. | 60505-3883 | ORAL | 25 mg in 1 1 | 12/5/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-822 | ORAL | 25 mg in 1 1 | 1/16/2018 | |
| Slate Run Pharmaceuticals, LLC | 70436-102 | ORAL | 25 mg in 1 1 | 10/22/2020 | |
| Camber Pharmaceuticals, Inc. | 31722-821 | ORAL | 12.5 mg in 1 1 | 1/16/2018 | |
| TAGI Pharma, Inc. | 51224-425 | ORAL | 12.5 mg in 1 1 | 1/30/2019 | |
| Sun Pharmaceutical Industries, Inc. | 47335-179 | ORAL | 25 mg in 1 1 | 8/10/2023 | |
| Apotex Corp. | 60505-3882 | ORAL | 12.5 mg in 1 1 | 12/5/2023 | |
| 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 |
|---|---|---|---|---|---|
| Tetrabenazine Tablets | 国药准字HJ20210040 | 化学药品 | 片剂 | 6/16/2021 | |
| Tetrabenazine Tablets | 国药准字HJ20230131 | 化学药品 | 片剂 | 11/28/2023 | |
| Tetrabenazine Tablets | 国药准字HJ20210041 | 化学药品 | 片剂 | 6/16/2021 | |
| Tetrabenazine Tablets | 国药准字HJ20230050 | 化学药品 | 片剂 | 5/12/2023 | |
| Tetrabenazine Tablets | 国药准字HJ20230051 | 化学药品 | 片剂 | 5/12/2023 |
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 | Medicine | A | 8/23/1991 | |
| TETRABENAZINE SUN tetrabenazine 25 mg tablet bottle | 381235 | Medicine | A | 11/28/2022 | |
| TETRABENAZINE RBX tetrabenazine 25 mg tablet bottle | 381236 | Medicine | A | 11/28/2022 | |
| TETRABENAZINE RAN tetrabenazine 25 mg tablet bottle | 381234 | Medicine | A | 11/28/2022 |
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