Overview
Benign prostatic hyperplasia (BPH) refers to a benign growth or hyperplasia of the prostate and leads to lower urinary tract symptoms in men, such as urgency, frequency and changes to urine flow. The prevalence of BPH is as high as 50%-60% for males in their 60's, and this prevalence increases to 80%-90% of those over 70. Alfuzosin is an alpha-1 adrenergic blocker used in the symptomatic treatment of BPH that works by relaxing the muscles in the prostate and bladder neck. It was initially approved by the FDA in 2003 and is marketed by several pharmaceutical companies.
Background
Benign prostatic hyperplasia (BPH) refers to a benign growth or hyperplasia of the prostate and leads to lower urinary tract symptoms in men, such as urgency, frequency and changes to urine flow. The prevalence of BPH is as high as 50%-60% for males in their 60's, and this prevalence increases to 80%-90% of those over 70. Alfuzosin is an alpha-1 adrenergic blocker used in the symptomatic treatment of BPH that works by relaxing the muscles in the prostate and bladder neck. It was initially approved by the FDA in 2003 and is marketed by several pharmaceutical companies.
Indication
Alfuzosin is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH).
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/06/13 | Phase 4 | Completed | |||
2008/06/03 | Phase 2 | Terminated | |||
2008/05/16 | Phase 2 | Completed | |||
2008/03/18 | Phase 4 | Completed | |||
2008/03/06 | Phase 3 | Completed | |||
2007/12/31 | Not Applicable | Withdrawn | |||
2007/12/19 | Phase 3 | Completed | |||
2007/12/18 | Phase 4 | Completed | |||
2007/11/26 | Not Applicable | Terminated | Hospital Authority, Hong Kong | ||
2007/10/26 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-6329 | ORAL | 10 mg in 1 1 | 3/27/2012 | |
| DirectRX | 61919-349 | ORAL | 10 mg in 1 1 | 1/17/2020 | |
| Aurobindo Pharma Limited | 65862-249 | ORAL | 10 mg in 1 1 | 1/6/2024 | |
| Physicians Total Care, Inc. | 54868-5046 | ORAL | 10 mg in 1 1 | 8/30/2012 | |
| Golden State Medical Supply, Inc. | 51407-829 | ORAL | 10 mg in 1 1 | 10/9/2023 | |
| Northwind Pharmaceuticals, LLC | 51655-087 | ORAL | 10 mg in 1 1 | 1/19/2023 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-306 | ORAL | 10 mg in 1 1 | 11/23/2021 | |
| Cipla USA Inc. | 69097-844 | ORAL | 10 mg in 1 1 | 5/28/2020 | |
| Exelan Pharmaceuticals Inc. | 76282-302 | ORAL | 10 mg in 1 1 | 12/1/2022 | |
| Wockhardt USA LLC. | 64679-738 | ORAL | 10 mg in 1 1 | 11/26/2019 |
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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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||