Overview
Diflunisal, a salicylate derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with pharmacologic actions similar to other prototypical NSAIAs. Diflunisal possesses anti-inflammatory, analgesic and antipyretic activity. Though its mechanism of action has not been clearly established, most of its actions appear to be associated with inhibition of prostaglandin synthesis via the arachidonic acid pathway. Diflunisal is used to relieve pain accompanied with inflammation and in the symptomatic treatment of rheumatoid arthritis and osteoarthritis.
Indication
For symptomatic treatment of mild to moderate pain accompanied by inflammation (e.g. musculoskeletal trauma, post-dental extraction, post-episiotomy), osteoarthritis, and rheumatoid arthritis.
Associated Conditions
- Mild pain
- Osteoarthritis (OA)
- Rheumatoid Arthritis
- Moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/03 | Phase 1 | Completed | |||
2012/08/30 | Phase 4 | Terminated | |||
2011/09/13 | N/A | Completed | |||
2006/02/22 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| H. J. Harkins Company Inc. | 52959-379 | ORAL | 500 mg in 1 1 | 12/21/2017 | |
| Chartwell RX, LLC | 62135-456 | ORAL | 500 mg in 1 1 | 2/1/2023 | |
| Zydus Lifesciences Limited | 70771-1083 | ORAL | 500 mg in 1 1 | 11/16/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-9222 | ORAL | 500 mg in 1 1 | 10/29/2021 |
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 |
|---|---|---|---|---|---|
| Diflunisal Tablets | 国药准字H20031174 | 化学药品 | 片剂 | 4/10/2020 | |
| Diflunisal Tablets | 国药准字H19990349 | 化学药品 | 片剂 | 8/7/2024 | |
| Diflunisal Tablets | 国药准字H20010747 | 化学药品 | 片剂 | 2/12/2020 | |
| Diflunisal Capsules | 国药准字H20163367 | 化学药品 | 胶囊剂 | 7/15/2021 | |
| Diflunisal Capsules | 国药准字H20163389 | 化学药品 | 胶囊剂 | 7/15/2021 | |
| Diflunisal Dispersible Tablets | 国药准字H20080293 | 化学药品 | 片剂 | 4/2/2023 |
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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