Overview
Chlormadinone acetate is a progesterone derivative first synthesized in 1961. In the US, chlormadinone acetate was formerly marketed as a component of the combination drug products Estalor-21 and C-Quens. However, the use of these drugs was associated with the development of mammary tumors in dogs. In 1972, the FDA withdrew its approval for the use of chlormadinone acetate in all products. Chlormadinone acetate continues to be used in other countries due to its high contraceptive efficacy and tolerability.
Background
Chlormadinone acetate is a progesterone derivative first synthesized in 1961. In the US, chlormadinone acetate was formerly marketed as a component of the combination drug products Estalor-21 and C-Quens. However, the use of these drugs was associated with the development of mammary tumors in dogs. In 1972, the FDA withdrew its approval for the use of chlormadinone acetate in all products. Chlormadinone acetate continues to be used in other countries due to its high contraceptive efficacy and tolerability.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/05/14 | Phase 4 | UNKNOWN | University Hospital of North Norway |
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 |
|---|---|---|---|---|---|
| BELARA film-coated tablet 0.03mg/2mg | SIN14870P | TABLET, FILM COATED | 2.000 mg | 10/14/2015 |
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. | |||||