Overview
Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.
Background
Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.
Indication
Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain. Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.
Associated Conditions
- Acute Gouty Arthritis
- Acute Migraine
- Ankylosing Spondylitis (AS)
- Back pain
- Bursitis
- Extra-Articular Rheumatism
- Fever
- Flu caused by Influenza
- Headache
- Juvenile Idiopathic Arthritis (JIA)
- Menstrual Distress (Dysmenorrhea)
- Migraine
- Muscle Spasms
- Nasal Congestion
- Osteoarthritis (OA)
- Pain
- Post Traumatic Pain
- Postoperative pain
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Seasonal Allergic Rhinitis
- Sinusitis
- Tendinitis
- Toothache
- Articular inflammation
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/03/27 | Phase 4 | Completed | |||
2017/01/23 | Phase 2 | Completed | |||
2016/12/08 | Phase 4 | Completed | Apkar Apkarian | ||
2016/07/28 | Phase 2 | Terminated | |||
2016/06/01 | Not Applicable | Completed | Shifa International Hospital | ||
2016/05/11 | Not Applicable | Completed | |||
2016/03/18 | Phase 2 | Completed | |||
2016/03/09 | Phase 2 | Completed | |||
2016/02/23 | Phase 4 | Terminated | |||
2016/01/29 | Phase 4 | Completed | Canadian Department of National Defense |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 71610-560 | ORAL | 500 mg in 1 1 | 6/24/2021 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-746 | ORAL | 500 mg in 1 1 | 2/3/2023 | |
| Physicians Total Care, Inc. | 54868-3043 | ORAL | 550 mg in 1 1 | 9/11/2012 | |
| A-S Medication Solutions | 50090-0468 | ORAL | 250 mg in 1 1 | 6/3/2021 | |
| DIRECT RX | 61919-165 | ORAL | 550 mg in 1 1 | 1/21/2020 | |
| Aurobindo Pharma Limited | 65862-520 | ORAL | 250 mg in 1 1 | 1/6/2024 | |
| Bryant Ranch Prepack | 71335-0822 | ORAL | 550 mg in 1 1 | 5/4/2021 | |
| Pharmaceutical Associates, Inc. | 0121-0899 | ORAL | 125 mg in 5 mL | 12/16/2020 | |
| Amneal Pharmaceuticals of New York LLC | 53746-189 | ORAL | 375 mg in 1 1 | 10/20/2021 | |
| Teva Pharmaceuticals, Inc. | 0480-0951 | ORAL | 375 mg in 1 1 | 6/30/2022 |
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 |
|---|---|---|---|---|---|
| Naproxen Capsules | 国药准字H53021525 | 化学药品 | 胶囊剂 | 6/8/2020 | |
| Naproxen Capsules | 国药准字H22021198 | 化学药品 | 胶囊剂 | 4/25/2020 | |
| Naproxen Capsules | 国药准字H23020162 | 化学药品 | 胶囊剂 | 5/18/2020 | |
| Naproxen Capsules | 国药准字H33020473 | 化学药品 | 胶囊剂 | 5/26/2020 | |
| Naproxen Capsules | 国药准字H51022680 | 化学药品 | 胶囊剂 | 2/26/2020 | |
| Naproxen Capsules | 国药准字H50020291 | 化学药品 | 胶囊剂 | 8/25/2020 | |
| Naproxen Capsules | 国药准字H34022896 | 化学药品 | 胶囊剂 | 6/4/2020 | |
| Naproxen Capsules | 国药准字H20065788 | 化学药品 | 胶囊剂 | 12/1/2022 | |
| Naproxen Capsules | 国药准字H22023863 | 化学药品 | 胶囊剂 | 4/19/2020 | |
| Naproxen Capsules | 国药准字H11020576 | 化学药品 | 胶囊剂 | 7/14/2021 |
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. | |||||