Overview
Overactive bladder (OAB) is a common condition negatively impacting the lives of millions of patients worldwide. Due to its urinary symptoms that include nocturia, urgency, and frequency, this condition causes social embarrassment and a poor quality of life. Oxybutynin, also marketed as Ditropan XL, is an anticholinergic medication used for the relief of overactive bladder symptoms that has been optimized for high levels of safety and efficacy since initial FDA approval in 1975. This drug relieves undesirable urinary symptoms, increasing the quality of life for patients affected by OAB. It is often used as first-line therapy for OAB.
Indication
Oxybutynin is indicated for the symptomatic treatment of overactive bladder, which causes urge urinary incontinence and frequency, and urgency. Oxybutynin may also be used for children aged 6 and above for the symptomatic management of detrusor muscle overactivity which has been found to be related to a neurological condition. Spina bifida is an example of a neurological condition in which oxybutynin may be used to control urinary symptoms. On occasion, oxybutynin may be used off-label to relieve bladder spasms associated with ureteral stents or urinary catheters.
Associated Conditions
- Bladder Spasms
- Detrusor Hyperreflexia
- Overactive Bladder Syndrome (OABS)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/09/15 | Phase 2 | Completed | |||
2014/06/27 | Phase 4 | Terminated | |||
2014/03/31 | Phase 3 | Withdrawn | |||
2013/10/08 | N/A | Completed | |||
2013/07/15 | Phase 4 | Completed | |||
2013/05/16 | Phase 3 | Completed | |||
2012/10/30 | Phase 3 | Completed | |||
2012/03/19 | Phase 3 | Completed | |||
2011/11/22 | Not Applicable | Completed | Centro de Reabilitação e Readaptação Dr. Henrique Santillo | ||
2011/08/26 | Phase 4 | UNKNOWN | Adana Numune Training and Research Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rising Pharma Holdings, Inc. | 64980-209 | ORAL | 5 mg in 1 1 | 3/29/2022 | |
| Chartwell RX, LLC | 62135-508 | ORAL | 10 mg in 1 1 | 3/6/2023 | |
| Aphena Pharma Solutions - Tennessee, Inc. | 43353-769 | ORAL | 10 mg in 1 1 | 3/26/2012 | |
| Physicians Total Care, Inc. | 54868-4502 | ORAL | 10 mg in 1 1 | 2/16/2012 | |
| Physicians Total Care, Inc. | 54868-5742 | ORAL | 5 mg in 1 1 | 1/21/2010 | |
| Ajanta Pharma USA Inc. | 27241-156 | ORAL | 10 mg in 1 1 | 5/25/2023 | |
| Novitium Pharma LLC | 70954-005 | ORAL | 5 mg in 1 1 | 8/24/2021 | |
| Ajanta Pharma USA Inc. | 27241-157 | ORAL | 15 mg in 1 1 | 5/25/2023 | |
| Physicians Total Care, Inc. | 54868-4835 | ORAL | 15 mg in 1 1 | 2/16/2012 | |
| Bryant Ranch Prepack | 71335-1494 | ORAL | 5 mg in 1 1 | 5/23/2023 |
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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PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RIVA-OXYBUTYNIN | laboratoire riva inc. | 02242109 | Tablet - Oral | 5 MG | 5/5/2000 |
| PAT-OXYBUTYNIN CHLORIDE ER | 02420015 | Tablet (Extended-Release) - Oral | 15 MG | N/A | |
| OXYBUTYNIN SYRUP | 02230943 | Syrup - Oral | 1 MG / ML | N/A | |
| DOM-OXYBUTYNIN 5 MG TABLETS | dominion pharmacal | 02241285 | Tablet - Oral | 5 MG | 12/16/1999 |
| MYLAN-OXYBUTYNIN | Mylan Pharmaceuticals ULC | 02230800 | Tablet - Oral | 5 MG | 4/24/1997 |
CIMA AEMPS Drug Approvals
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|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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