Overview
Prednisolone acetate is a prednisolone molecule bound to an acetate functional group by an ester bond. Prednisolone acetate was granted FDA approval in 1955.
Background
Prednisolone acetate is a prednisolone molecule bound to an acetate functional group by an ester bond. Prednisolone acetate was granted FDA approval in 1955.
Indication
Prednisolone acetate is indicated as an anti-inflammatory or immunosuppressive agent for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, or infectious conditions. Prednisolone acetate is also indicated in organ transplant patients, as well as endocrine or neoplastic conditions.
Associated Conditions
- Inflammation
- Inflammatory Conditions
- Ocular Infections, Irritations and Inflammations
- Ocular Inflammation
- Transplanted Organ Rejection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/07 | Phase 2 | Completed | VivaVision Biotech, Inc | ||
2023/03/14 | Phase 4 | Recruiting | Baoping XU | ||
2022/11/17 | Early Phase 1 | Recruiting | |||
2022/07/18 | Phase 2 | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2021/04/28 | Phase 4 | UNKNOWN | |||
2020/09/24 | Phase 4 | Terminated | |||
2020/07/09 | Phase 4 | Terminated | Midwest Eye Institute | ||
2020/04/17 | Phase 4 | Completed | Brandon Eye Associates, PA | ||
2020/02/18 | Phase 4 | Completed | |||
2019/11/19 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-0561 | OPHTHALMIC | 10 mg in 1 mL | 1/20/2016 | |
| DIRECT RX | 72189-055 | OPHTHALMIC | 10 mg in 1 mL | 10/30/2019 | |
| NuCare Pharmaceuticals,Inc. | 68071-2222 | OPHTHALMIC | 10 mg in 1 mL | 2/4/2022 | |
| Imprimis NJOF, LLC | 71384-505 | OPHTHALMIC | 10 mg in 1 mL | 1/19/2018 | |
| Pacific Pharma, Inc. | 60758-119 | OPHTHALMIC | 10 mg in 1 mL | 4/4/2024 | |
| Physicians Total Care, Inc. | 54868-1157 | OPHTHALMIC | 2 mg in 1 g | 3/4/2012 | |
| Physicians Total Care, Inc. | 54868-6355 | OPHTHALMIC | 1.2 mg in 1 mL | 1/2/2013 | |
| ImprimisRx NJ | 70261-502 | OPHTHALMIC | 10 mg in 1 mL | 2/22/2018 | |
| Physicians Total Care, Inc. | 54868-0634 | OPHTHALMIC | 2 mg in 1 mL | 11/15/2013 | |
| REMEDYREPACK INC. | 70518-4006 | OPHTHALMIC | 10 mg in 1 mL | 2/2/2024 |
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 |
|---|---|---|---|---|---|
| PRED FORTE OPHTHALMIC SUSPENSION 1% | SIN04661P | SOLUTION | 10 mg/ml | 6/13/1990 |
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 |
|---|---|---|---|---|---|
| PREDNEFRIN FORTE phenylephrine hydrochloride/prednisolone acetate eye drops bottle | 23235 | Medicine | A | 10/14/1991 |