Overview
Nepafenac is a non-steroidal anti-inflammatory prodrug (NSAID) usually sold as a prescription eye drop. It is used to treat pain and inflammation associated with cataract surgery.
Background
Nepafenac is a non-steroidal anti-inflammatory prodrug (NSAID) usually sold as a prescription eye drop. It is used to treat pain and inflammation associated with cataract surgery.
Indication
For the treatment of pain and inflammation associated with cataract surgery.
Associated Conditions
- Inflammation
- Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/18 | Phase 4 | Recruiting | Oslo University Hospital | ||
2021/10/08 | Phase 4 | Recruiting | Oslo University Hospital | ||
2021/04/14 | Phase 2 | UNKNOWN | |||
2019/04/17 | Phase 4 | UNKNOWN | |||
2019/03/22 | Phase 4 | Completed | |||
2019/02/22 | Phase 2 | UNKNOWN | |||
2018/07/24 | Phase 3 | Completed | |||
2018/04/17 | Phase 3 | Completed | |||
2018/01/23 | Not Applicable | Completed | University Hospital of Patras | ||
2017/01/20 | Not Applicable | Completed | Intuor Technologies, Inc. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0778 | OPHTHALMIC | 1 mg in 1 mL | 9/6/2021 | |
| Novartis Pharmaceuticals Corporation | 0078-0743 | OPHTHALMIC | 3 mg in 1 mL | 3/17/2020 | |
| Physicians Total Care, Inc. | 54868-6302 | OPHTHALMIC | 1 mg in 1 mL | 8/31/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/11/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Nevanac® Eye Drops Suspension 1 mg/ml | SIN13759P | SUSPENSION, STERILE | 1.0 mg/ml | 1/28/2010 |
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 |
|---|---|---|---|---|---|
| ILEVRO nepafenac 0.3% eye drops, suspension, oval bottle | 309880 | Medicine | A | 8/30/2019 | |
| ILEVRO nepafenac 0.3% eye drops, suspension, bottle | 230200 | Medicine | A | 11/4/2015 |