Overview
Levocabastine is a selective second-generation H1-receptor antagonist used for allergic conjunctivitis. Levocabastine was discovered at Janssen Pharmaceutica in 1979.
Background
Levocabastine is a selective second-generation H1-receptor antagonist used for allergic conjunctivitis. Levocabastine was discovered at Janssen Pharmaceutica in 1979.
Indication
As an ophthalmic for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. Also used as a nasal spray for allergic rhinitis.
Associated Conditions
- Allergic Conjunctivitis (AC)
- Allergic Rhinitis (AR)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/06/28 | Not Applicable | UNKNOWN | Beijing Tongren Hospital | ||
2015/07/15 | Phase 3 | Completed | |||
2013/10/08 | Phase 2 | Completed | |||
2013/09/24 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Levocabastine Hydrochloride Nasal Spray | 国药准字HJ20160305 | 化学药品 | 鼻喷雾剂 | 3/22/2021 | |
| Levocabastine Hydrochloride Nasal Spray | 国药准字HJ20160304 | 化学药品 | 鼻喷雾剂 | 3/22/2021 |
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 |
|---|---|---|---|---|---|
| LIVOSTIN levocabastine hydrochloride 0.54 mg/mL nasal spray solution bottle | 48290 | Medicine | A | 5/6/1994 | |
| ZYRTEC Eye Drops levocabastine hydrochloride 0.54 mg/mL eye drops bottle | 227289 | Medicine | A | 8/27/2014 | |
| LIVOSTIN EYE DROPS levocabastine hydrochloride 0.54 mg/mL eye drops suspension bottle | 48289 | Medicine | A | 5/6/1994 | |
| ZYRTEC levocabastine hydrochloride 0.54 mg/mL nasal spray bottle | 227290 | Medicine | A | 8/27/2014 |