Overview
Fesoterodine is an antimuscarinic prodrug for the treatment of overactive bladder syndrome.
Indication
适用于治疗急迫性尿失禁和膀胱过度活动综合征患者的尿频、尿急、尿失禁或所有这些症状组合。
Associated Conditions
- Neurogenic Detrusor Overactivity
- Overactive Bladder Syndrome (OABS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/07/01 | Phase 1 | Completed | |||
2019/05/10 | Phase 4 | Completed | |||
2018/07/27 | N/A | Completed | |||
2018/06/28 | N/A | Completed | |||
2016/02/08 | Phase 2 | Completed | |||
2015/11/25 | Phase 3 | Completed | Stéphane Bolduc | ||
2015/07/17 | Phase 3 | Completed | |||
2015/03/11 | Phase 4 | Terminated | Sir Mortimer B. Davis - Jewish General Hospital | ||
2014/12/31 | Phase 3 | Completed | Stéphane Bolduc | ||
2014/10/13 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Pharmaceuticals USA Inc. | 68382-479 | ORAL | 4 mg in 1 1 | 4/2/2024 | |
| ANI Pharmaceuticals, Inc. | 62559-376 | ORAL | 8 mg in 1 1 | 1/4/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-618 | ORAL | 4 mg in 1 1 | 1/31/2023 | |
| Ascend Laboratories, LLC | 67877-068 | ORAL | 8 mg in 1 1 | 4/11/2022 | |
| AvKARE | 42291-053 | ORAL | 4 mg in 1 1 | 11/7/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-033 | ORAL | 4 mg in 1 1 | 3/26/2024 | |
| Aurobindo Pharma Limited | 65862-767 | ORAL | 8 mg in 1 1 | 8/30/2023 | |
| Zydus Pharmaceuticals USA Inc. | 68382-480 | ORAL | 8 mg in 1 1 | 4/2/2024 | |
| Physicians Total Care, Inc. | 54868-6175 | ORAL | 8 mg in 1 1 | 4/6/2012 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0244 | ORAL | 8 mg in 1 1 | 11/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/20/2007 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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