Overview
Balsalazide is an anti-inflammatory drug used in the treatment of Inflammatory Bowel Disease. It is sold under the name "Colazal" in the US and "Colazide" in the UK. The chemical name is (E)-5-[[-4-(2-carboxyethyl) aminocarbonyl] phenyl]azo] -2-hydroxybenzoic acid. It is usually administered as the disodium salt. Balsalazide works by deliverying mesalazine to the large intestine to act directly on ulcerative colitis. Mesalazine is also known as 5-aminosalicylic acid, or 5-ASA.
Indication
For the treatment of mildly to moderately active ulcerative colitis.
Associated Conditions
- Mild Ulcerative Colitis
- Moderate Ulcerative colitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/04/01 | Phase 1 | Completed | |||
2008/04/01 | Phase 1 | Completed | |||
2008/02/19 | Not Applicable | Completed | |||
2008/02/19 | Not Applicable | Completed | |||
2007/06/13 | Phase 3 | Completed | |||
2006/12/06 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 51407-820 | ORAL | 750 mg in 1 1 | 12/19/2023 | |
| Zydus Lifesciences Limited | 70771-1841 | ORAL | 750 mg in 1 1 | 11/7/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-149 | ORAL | 750 mg in 1 1 | 2/8/2024 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1626 | ORAL | 750 mg in 1 1 | 3/29/2024 | |
| Physicians Total Care, Inc. | 54868-6137 | ORAL | 750 mg in 1 1 | 3/14/2011 | |
| Apotex Corp. | 60505-2575 | ORAL | 750 mg in 1 1 | 12/6/2023 | |
| Oceanside Pharmaceuticals | 68682-750 | ORAL | 750 mg in 1 1 | 6/2/2016 | |
| Salix Pharmaceuticals, Inc | 65649-101 | ORAL | 750 mg in 1 1 | 11/2/2023 | |
| Bryant Ranch Prepack | 72162-2095 | ORAL | 750 mg in 1 1 | 9/18/2023 | |
| AvPAK | 50268-102 | ORAL | 750 mg in 1 1 | 1/9/2024 |
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 |
|---|---|---|---|---|---|
| Balsalazide sodium Tablets | 国药准字H20041706 | 化学药品 | 片剂 | 6/22/2020 | |
| Balsalazide Sodium Capsules | 国药准字H20061083 | 化学药品 | 胶囊剂 | 5/14/2020 | |
| Balsalazide Sodium Capsules | 国药准字H20061084 | 化学药品 | 胶囊剂 | 4/28/2020 | |
| Balsalazide Sodium Capsules | 国药准字H20194078 | 化学药品 | 胶囊剂 | 9/14/2024 | |
| Balsalazide Sodium Granules | 国药准字H20030748 | 化学药品 | 颗粒剂 | 5/19/2020 |
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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