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.
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 |
|---|---|---|---|---|---|
2007/10/10 | Phase 4 | Completed | |||
2007/10/08 | Phase 3 | Completed | |||
2007/06/15 | Phase 4 | Completed | |||
2007/04/30 | Phase 3 | Completed | |||
2007/03/30 | Phase 3 | Terminated | |||
2007/03/29 | Phase 3 | Terminated | |||
2007/03/22 | Phase 4 | UNKNOWN | |||
2007/01/29 | Phase 4 | Completed | |||
2006/11/20 | Phase 4 | Completed | |||
2006/11/14 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 43353-746 | ORAL | 10 mg in 1 1 | 7/25/2017 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-155 | ORAL | 10 mg in 1 1 | 3/25/2022 | |
| Wockhardt Limited | 55648-738 | ORAL | 10 mg in 1 1 | 7/20/2012 | |
| Bryant Ranch Prepack | 63629-9295 | ORAL | 10 mg in 1 1 | 12/18/2020 | |
| Stat Rx USA | 16590-279 | ORAL | 10 mg in 1 1 | 10/27/2009 | |
| Camber Pharmaceuticals | 31722-302 | ORAL | 10 mg in 1 1 | 1/18/2012 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | ORAL | 10 mg in 1 1 | 5/22/2014 | |
| Apotex Corp. | 60505-2850 | ORAL | 10 mg in 1 1 | 9/8/2023 | |
| Sun Pharmaceutical Industries, Inc. | 47335-956 | ORAL | 10 mg in 1 1 | 1/19/2024 |
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| No UK EMC drug information found for this drug. | |||||
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