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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/08/07 | Phase 1 | UNKNOWN | |||
2012/06/06 | Phase 2 | Terminated | |||
2012/04/30 | Phase 4 | Completed | |||
2012/03/20 | Not Applicable | UNKNOWN | Analgesic Solutions | ||
2012/02/27 | Early Phase 1 | Completed | |||
2012/02/02 | Phase 4 | Completed | International Clinical Research Institute | ||
2011/12/20 | Phase 3 | Completed | |||
2011/11/16 | Phase 3 | Completed | EMS | ||
2011/11/16 | Phase 3 | Completed | EMS | ||
2011/11/09 | Phase 3 | Completed | Targeted Medical Pharma |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4637 | ORAL | 375 mg in 1 1 | 6/1/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-003 | ORAL | 500 mg in 1 1 | 9/22/2023 | |
| Bryant Ranch Prepack | 63629-8515 | ORAL | 500 mg in 1 1 | 7/21/2021 | |
| Northwind Pharmaceuticals, LLC | 82868-030 | ORAL | 375 mg in 1 1 | 1/1/2024 | |
| Cipla USA Inc. | 69097-854 | ORAL | 375 mg in 1 1 | 8/20/2019 | |
| Amneal Pharmaceuticals of New York LLC | 53746-190 | ORAL | 500 mg in 1 1 | 10/20/2021 | |
| Zydus Pharmaceuticals USA Inc. | 68382-013 | ORAL | 375 mg in 1 1 | 11/10/2022 | |
| Quality Care Products, LLC | 55700-888 | ORAL | 500 mg in 1 1 | 3/18/2021 | |
| Blenheim Pharmacal, Inc. | 10544-920 | ORAL | 500 mg in 1 1 | 6/5/2015 | |
| Biomes Pharmaceuticals | 69150-140 | ORAL | 500 mg in 1 1 | 6/19/2016 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Naproxen Capsules | 国药准字H41023068 | 化学药品 | 胶囊剂 | 8/4/2020 | |
| Naproxen Capsules | 国药准字H23022406 | 化学药品 | 胶囊剂 | 6/29/2020 | |
| Naproxen Capsules | 国药准字H50021039 | 化学药品 | 胶囊剂 | 8/25/2020 | |
| Naproxen Capsules | 国药准字H34022888 | 化学药品 | 胶囊剂 | 6/18/2020 | |
| Naproxen Capsules | 国药准字H15020979 | 化学药品 | 胶囊剂 | 5/7/2020 | |
| Naproxen Capsules | 国药准字H52020047 | 化学药品 | 胶囊剂 | 12/13/2019 | |
| Naproxen Capsules | 国药准字H13021514 | 化学药品 | 胶囊剂 | 4/23/2020 | |
| Naproxen Capsules | 国药准字H22021071 | 化学药品 | 胶囊剂 | 1/9/2020 | |
| Naproxen Capsules | 国药准字H44023491 | 化学药品 | 胶囊剂 | 4/8/2020 | |
| Naproxen Capsules | 国药准字H33021522 | 化学药品 | 胶囊剂 | 4/26/2020 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||