Overview
Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .
Indication
Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults
Associated Conditions
- Ankylosing Spondylitis (AS)
- Duodenal Ulcer
- Erosive Esophagitis
- Gastric Ulcer
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Heartburn
- Helicobacter Pylori Infection
- Osteoarthritis (OA)
- Rheumatoid Arthritis
- Upper GI Bleeding
- Zollinger-Ellison Syndrome
- Benign, active Gastric Ulcer
- Develop NSAID-induced gastric ulcers
- Hypersecretory conditions
- Multiple endocrine adenomas
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/07/30 | Phase 1 | Completed | |||
2013/07/17 | Phase 4 | Completed | Daniel Freedberg, MD | ||
2013/07/11 | Phase 4 | Completed | |||
2013/05/13 | Phase 4 | Completed | |||
2013/04/04 | Early Phase 1 | Withdrawn | |||
2013/04/04 | Phase 1 | Completed | |||
2013/04/02 | Phase 4 | Completed | |||
2013/03/19 | Phase 1 | Completed | |||
2013/02/21 | Phase 4 | UNKNOWN | |||
2013/02/08 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 65841-759 | ORAL | 10 mg in 1 1 | 9/27/2023 | |
| Covis Pharma US, Inc | 70515-625 | ORAL | 2.5 mg in 1 1 | 12/17/2021 | |
| Lannett Company, Inc. | 62175-136 | ORAL | 40 mg in 1 1 | 4/21/2023 | |
| NorthStar Rx LLC | 16714-634 | ORAL | 20 mg in 1 1 | 6/15/2023 | |
| Northwind Pharmaceuticals | 51655-061 | ORAL | 20 mg in 1 1 | 12/31/2021 | |
| Golden State Medical Supply, Inc. | 51407-129 | ORAL | 20 mg in 1 1 | 10/16/2023 | |
| Golden State Medical Supply, Inc. | 51407-256 | ORAL | 20 mg in 1 1 | 10/16/2023 | |
| Dr.Reddy's Laboratories Limited | 55111-364 | ORAL | 40 mg in 1 1 | 3/20/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4024 | ORAL | 20 mg in 1 1 | 2/12/2021 | |
| Cardinal Health 107, LLC | 55154-8191 | ORAL | 20 mg in 1 1 | 12/22/2022 |
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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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Omeprazole Sodium for Injection | 国药准字H20054125 | 化学药品 | 注射剂 | 11/22/2019 | |
| Omeprazole Sodium for Injection | 国药准字H20054548 | 化学药品 | 注射剂 | 10/9/2020 | |
| Omeprazole Sodium for Injection | 国药准字H20103381 | 化学药品 | 注射剂 | 8/21/2020 | |
| Omeprazole Sodium for Injection | 国药准字H20123034 | 化学药品 | 注射剂 | 9/7/2020 | |
| Omeprazole Sodium for Injection | 国药准字H20056145 | 化学药品 | 注射剂 | 10/9/2023 | |
| Omeprazole Sodium for Injection | 国药准字H20055282 | 化学药品 | 注射剂 | 8/11/2020 | |
| Omeprazole Sodium for Injection | 国药准字H20083793 | 化学药品 | 注射剂 | 1/14/2023 | |
| Omeprazole Sodium for Injection | 国药准字H20063736 | 化学药品 | 注射剂 | 2/20/2021 | |
| Omeprazole Sodium for Injection | 国药准字H20066641 | 化学药品 | 注射剂 | 1/25/2021 | |
| Omeprazole Sodium for Injection | 国药准字H20073284 | 化学药品 | 注射剂 | 7/30/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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