Drugs / Tetrabenazine
Tetrabenazine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XENAZINE | — | 2008-08-15 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01133353 | Mar → Nov 2011 | Tourette syndrome | Bausch Health Americas, Inc. | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01543321 | May 2012 → May 2017 | tardive dyskinesia | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 3 | NCT00219804 | — | Huntington disease | Prestwick Pharmaceuticals | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02509793 | Aug 2018 → Jul 2023 | Huntington disease | William Ondo, MD | Unknown | No outcome recorded |
| Phase 4 | NCT01834911 | Mar 2013 → Jan 2018 | Huntington disease | New York Medical College | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00362804 | Feb 2002 → Jan 2006 | schizoaffective disorder, schizophrenia | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00642057 | — | movement disorder | Joseph Jankovic | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT00632645 Comparator | Apr 2009 → Apr 2017 | Huntington disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-04-23 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Xenazine® Tablets, 12.5 mg and 25 mg lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received final approval for its Tetrabenazine Tablets, 12.5 mg and 25 mg from the United States Food and Drug Administration (FDA) to market a generic version of Valeant Pharmaceuticals North America, LLC’s Xenazine® Tablets, 12.5 mg and 25 mg. |
| 2017-03-23 | Medicure | Regulatory Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine medicure.com ↗
Medicure Inc. (" Medicure " or the " Company ") (TSXV:MPH, OTC:MCUJF), a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for the Company's abbreviated new drug application ("ANDA") for tetrabenazine tablets in the 12.5 mg and 25 mg strengths. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-12-05 | Lupin Limited | Lupin launches generic Tetrabenazine Tablets lupin.com ↗ |
| 2018-04-23 | Lupin Limited | Lupin receives FDA approval for generic Xenazine® Tablets, 12.5 mg and 25 mg lupin.com ↗ |
| 2017-03-23 | Medicure | Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine medicure.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tetrabenazine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00362804 ↗ |
| Known as | TBZ | “With a variety of other potential augmentation strategies available, we have chosen to focus on tetrabenazine (TBZ), which is currently licensed here in Canada for the...” NCT00362804 ↗1“Tetrabenazine (TBZ) selectively depletes central monoamines by reversibly binding to the type-2 vesicular monoamine transporter.” PMID 20021666 ↗ Dec 2009 |
| Known as | Xenazine | “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗2“Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks” NCT02509793 ↗ |
| Known as | Xenazine (tetrabenazine) | “Xenazine (tetrabenazine)” NCT01543321 ↗ |
| Action | Inhibit | “inhibitor of vesicular monoamine transporter” NCT00362804 ↗ |
| Route | Oral | “Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg” NCT00632645 ↗ |