Overview
Oxybuprocaine (also known as Benoxinate) is a local anesthetic, which is used especially in ophthalmology and otolaryngology. Oxybuprocaine binds to sodium channels and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions.
Indication
Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/17 | Phase 3 | Completed | |||
2023/07/03 | Phase 3 | Completed | |||
2022/12/27 | Phase 4 | Completed | |||
2019/12/10 | Not Applicable | Completed | |||
2019/05/01 | Phase 2 | Completed | |||
2015/08/19 | Not Applicable | Completed | |||
2013/07/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | 24208-734 | OPHTHALMIC | 4.4 mg in 1 mL | 8/31/2022 | |
| Oceanside Pharmaceuticals | 68682-732 | OPHTHALMIC | 4.4 mg in 1 mL | 3/19/2020 | |
| Bausch & Lomb Americas Inc. | 82260-734 | OPHTHALMIC | 4.4 mg in 1 mL | 3/16/2023 | |
| Altaire Pharmaceuticals Inc. | 59390-218 | OPHTHALMIC | 4 mg in 1 mL | 12/2/2022 |
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 |
|---|---|---|---|---|---|
| Oxybuprocaine Hydrochloride Gel | 国药准字H21023203 | 化学药品 | 凝胶剂 | 5/9/2020 | |
| Oxybuprocaine Hydrochloride Gel | 国药准字H21023097 | 化学药品 | 凝胶剂 | 5/9/2020 | |
| Oxybuprocaine Hydrochloride Eye Drops | 国药准字H21023202 | 化学药品 | 滴眼剂 | 1/8/2021 | |
| Oxybuprocaine Hydrochloride Eye Drops | 国药准字H20056587 | 化学药品 | 滴眼剂 | 3/10/2020 | |
| Oxybuprocaine Hydrochloride Eye Drops | 国药准字H20249589 | 化学药品 | 眼用制剂 | 12/1/2024 | |
| Oxybuprocaine Hydrochloride Eye Drops | 国药准字HJ20215002 | 化学药品 | 滴眼剂 | 11/20/2020 |
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 |
|---|---|---|---|---|---|
| Minims Oxybuprocaine Hydrochloride 0.4% 4mg/mL eye drops tube | 32259 | Medicine | A | 10/30/1991 |
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