Overview
Ménière's disease is a progressive disease of the inner ear characterized by vertigo, tinnitus, and hearing loss. It has a significant impact on both the physical and social functioning of affected individuals. Betahistine is a histamine-like antivertigo drug used for treating symptoms associated with Ménière's disease. It is thought to reduce symptoms through its actions on histamine receptors. Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy. It is currently marketed in Canada by various companies, including Teva Pharmaceuticals.
Background
Ménière's disease is a progressive disease of the inner ear characterized by vertigo, tinnitus, and hearing loss. It has a significant impact on both the physical and social functioning of affected individuals. Betahistine is a histamine-like antivertigo drug used for treating symptoms associated with Ménière's disease. It is thought to reduce symptoms through its actions on histamine receptors. Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy. It is currently marketed in Canada by various companies, including Teva Pharmaceuticals.
Indication
Betahistine is indicated for the reduction of recurrent vertigo episodes associated with Ménière's disease in patients 18 years old and above.
Associated Conditions
- Menière's Disease
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/09/08 | Phase 2 | Completed | |||
2008/07/03 | Phase 2 | Completed | |||
2008/01/03 | Phase 2 | Terminated | |||
2007/05/16 | Phase 4 | Withdrawn | |||
2007/04/27 | Phase 2 | Terminated | |||
2007/04/13 | Phase 1 | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
2007/01/29 | Phase 2 | Terminated | |||
2006/12/08 | Phase 2 | Completed | |||
2005/09/12 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Betahistine Hydrochloride Oral Solution | 国药准字H20184109 | 化学药品 | 口服溶液剂 | 7/8/2023 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20066114 | 化学药品 | 口服溶液剂 | 5/27/2023 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20084489 | 化学药品 | 口服溶液剂 | 12/14/2023 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H10920134 | 化学药品 | 口服溶液剂 | 5/12/2020 | |
| Betahistine Hydrochloride Tablets | 国药准字H20247121 | 化学药品 | 片剂 | 6/5/2024 | |
| Betahistine Hydrochloride Tablets | 国药准字H41025663 | 化学药品 | 片剂 | 1/8/2020 | |
| Betahistine Hydrochloride Tablets | 国药准字H44022848 | 化学药品 | 片剂(糖衣) | 11/27/2020 | |
| Betahistine Hydrochloride Tablets | 国药准字H21020945 | 化学药品 | 片剂 | 8/26/2020 | |
| Betahistine Hydrochloride Tablets | 国药准字H23021802 | 化学药品 | 片剂(糖衣) | 6/4/2020 | |
| Betahistine Hydrochloride Tablets | 国药准字H44022849 | 化学药品 | 片剂(糖衣) | 11/27/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SERC betahistine dihydrochloride 16 mg tablet blister pack | 61687 | Medicine | A | 11/5/1997 | |
| BETAHISTAVERT betahistine dihydrochloride 16 mg tablets blister packs | 227606 | Medicine | A | 9/5/2014 | |
| SERC betahistine dihydrochloride 8 mg tablet blister pack | 61688 | Medicine | A | 11/5/1997 | |
| SERBEHISTIN betahistine dihydrochloride 16 mg tablets blister packs | 212083 | Medicine | A | 8/14/2014 | |
| BETAHISTINE VIATRIS betahistine dihydrochloride 16 mg uncoated tablet blister pack | 286806 | Medicine | A | 8/29/2017 | |
| BETAHISTINE SCP betahistine dihydrochloride 16mg tablet blister pack | 367216 | Medicine | A | 8/12/2021 | |
| SETEAR betahistine dihydrochloride 16mg tablet blister pack | 367218 | Medicine | A | 8/12/2021 | |
| BETAHIST betahistine dihydrochloride 16 mg tablets blister packs | 212079 | Medicine | A | 8/14/2014 | |
| BETAHISTINE SCP betahistine dihydrochloride 24 mg tablet blister pack | 261437 | Medicine | A | 3/2/2017 | |
| BETAHISTINE RMB betahistine dihydrochloride 16mg tablet blister pack | 367217 | Medicine | A | 8/12/2021 |