Overview
Difluprednate is a topical corticosteroid indicated for the treatment of infammation and pain associated with ocular surgery. It is a butyrate ester of 6(α), 9(α)-difluoro prednisolone acetate. Difluprednate is abbreviated DFBA, or difluoroprednisolone butyrate acetate. It is indicated for treatment of endogenous anterior uveiti.
Indication
For the treatment of inflammation and pain associated with ocular surgery.
Associated Conditions
- Anterior Uveitis (AU)
- Endogenous Anterior Uveitis
- Eye Pain
- Ocular Inflammation
- Pain of the eye
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/22 | Phase 3 | Recruiting | |||
2022/12/13 | Phase 4 | Recruiting | |||
2020/12/29 | Phase 4 | Terminated | Cathleen McCabe MD | ||
2020/11/17 | Phase 4 | Completed | Laboratorios Poen | ||
2019/09/20 | Phase 3 | Completed | Thomas M. Lietman | ||
2018/10/03 | Phase 3 | Completed | |||
2018/02/08 | Phase 3 | Completed | |||
2013/09/11 | Phase 4 | Terminated | |||
2011/01/13 | Phase 2 | Completed | |||
2010/11/19 | Phase 4 | Completed | Edward J. Holland |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 0781-6000 | OPHTHALMIC | 0.5 mg in 1 mL | 9/27/2021 | |
| Dr. Reddy's Laboratories Inc. | 43598-588 | OPHTHALMIC | 0.5 mg in 1 mL | 7/1/2020 | |
| Cipla USA Inc. | 69097-341 | OPHTHALMIC | 0.5 mg in 1 mL | 4/10/2020 | |
| Physicians Total Care, Inc. | 54868-6296 | OPHTHALMIC | 0.5 mg in 1 mL | 9/2/2011 | |
| Exelan Pharmaceuticals, Inc. | 76282-708 | OPHTHALMIC | 0.5 mg in 1 mL | 12/10/2021 | |
| Novartis Pharmaceuticals Corporation | 0078-0862 | OPHTHALMIC | 0.5 mg in 1 mL | 11/15/2020 | |
| Amneal Pharmaceuticals NY LLC | 69238-1380 | OPHTHALMIC | 0.5 mg in 1 mL | 12/29/2023 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DUREZOL | novartis pharmaceuticals canada inc | 02415534 | Emulsion - Ophthalmic | 0.05 % / W/V | 2/19/2014 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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