Overview
Cevimeline is a parasympathomimetic agent that act as an agonist at the muscarinic acetylcholine receptors M1 and M3. It is indicated by the Food and Drug Administration for the treatment of dry mouth associated with Sjögren's syndrome.
Background
Cevimeline is a parasympathomimetic agent that act as an agonist at the muscarinic acetylcholine receptors M1 and M3. It is indicated by the Food and Drug Administration for the treatment of dry mouth associated with Sjögren's syndrome.
Indication
用于治疗各型青光眼。FDA批准用于干燥综合征和放疗引起的口干症。
Associated Conditions
- Dry Mouth
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/07/19 | Early Phase 1 | Completed | |||
2013/07/19 | Early Phase 1 | Completed | |||
2012/09/21 | Not Applicable | Completed | |||
2007/04/24 | Phase 4 | Completed | American Academy of Otolaryngology-Head and Neck Surgery Foundation | ||
2003/01/27 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lupin Pharmaceuticals,Inc. | 43386-999 | ORAL | 30 mg in 1 1 | 1/30/2024 | |
| Advagen Pharma Ltd | 72888-118 | ORAL | 30 mg in 1 1 | 5/3/2023 | |
| Daiichi Sankyo, Inc. | 63395-201 | ORAL | 30 mg in 1 1 | 6/3/2022 | |
| Cosette Pharmaceuticals, Inc. | 0713-0937 | ORAL | 30 mg in 1 1 | 1/5/2023 | |
| Sun Pharmaceutical Industries, Inc. | 63304-479 | ORAL | 30 mg in 1 1 | 7/15/2022 | |
| Novel Laboratories, Inc. | 40032-999 | ORAL | 30 mg in 1 1 | 2/9/2016 | |
| Bryant Ranch Prepack | 63629-9863 | ORAL | 30 mg in 1 1 | 8/3/2018 | |
| Cosette Pharmaceuticals, Inc. | 0713-0883 | ORAL | 30 mg in 1 1 | 9/7/2022 | |
| STAT RX USA LLC | 16590-859 | ORAL | 30 mg in 1 1 | 8/2/2011 | |
| Aurobindo Pharma Limited | 59651-422 | ORAL | 30 mg in 1 1 | 7/2/2022 |
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 |
|---|---|---|---|---|---|
| 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. | |||||