Overview
Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name Talion. It is available in oral and opthalmic dosage forms in Japan. The opthalmic solution is FDA approved since Sept 8, 2009 and is under the brand name Bepreve.
Indication
用于治疗过敏性鼻炎；荨麻疹；皮肤疾病引起的瘙痒（湿疹•皮炎、痒疹、皮肤瘙痒症）。
Associated Conditions
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/05/07 | Phase 4 | Completed | |||
2021/03/01 | Phase 4 | Completed | Laboratorios Poen | ||
2021/01/05 | Phase 1 | Completed | |||
2018/08/31 | Phase 3 | Completed | |||
2017/10/23 | Phase 3 | Completed | |||
2016/02/19 | Phase 1 | Completed | |||
2016/02/15 | Phase 1 | Completed | |||
2015/01/06 | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | ||
2013/07/16 | Phase 3 | Completed | |||
2013/05/23 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Inc. | 62332-598 | OPHTHALMIC | 15 mg in 1 mL | 7/21/2023 | |
| Alembic Pharmaceuticals Limited | 46708-598 | OPHTHALMIC | 15 mg in 1 mL | 7/21/2023 | |
| Physicians Total Care, Inc. | 54868-6299 | OPHTHALMIC | 15 mg in 1 mL | 10/3/2011 | |
| Mylan Pharmaceuticals Inc. | 0378-7055 | OPHTHALMIC | 15 mg in 1 mL | 3/20/2018 | |
| Bausch & Lomb Americas Inc. | 82260-630 | OPHTHALMIC | 15 mg in 1 mL | 8/31/2022 | |
| Bausch & Lomb Incorporated | 24208-629 | OPHTHALMIC | 15 mg in 1 mL | 8/31/2022 | |
| Apotex Corp. | 60505-6111 | OPHTHALMIC | 15 mg in 1 mL | 8/11/2022 | |
| Bausch & Lomb Incorporated | 24208-630 | OPHTHALMIC | 15 mg in 1 mL | 12/31/2020 |
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 |
|---|---|---|---|---|---|
| Bepotastine Besilate Orally Disintegrating Tablets | 国药准字H20233733 | 化学药品 | 片剂 | 6/14/2023 | |
| Bepotastine Besilate Tablets | H20150606 | 化学药品 | 片剂 | 2/4/2020 | |
| Bepotastine Besilate Tablets | 国药准字H20223928 | 化学药品 | 片剂 | 12/30/2022 | |
| Bepotastine Besilate Tablets | 国药准字J20150093 | 化学药品 | 片剂 | 4/10/2020 | |
| Bepotastine Besilate Tablets | H20150605 | 化学药品 | 片剂 | 2/4/2020 | |
| Bepotastine Besilate Tablets | 国药准字H20193370 | 化学药品 | 片剂 | 8/2/2024 | |
| Bepotastine Besilate Tablets | 国药准字H20213162 | 化学药品 | 片剂 | 3/9/2021 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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