Overview
Esterified estrogens contain a mixture of estrogenic substances; the principle component is estrone. Preparations contain 75% to 85% sodium estrone sulfate and 6% to 15% sodium equilin sulfate such that the total is not <90%. Esterified estrogens are a man-made mixture of estrogens that are used to treat symptoms of menopause such as hot flashes, vaginal dryness, vaginal burning or irritation, or other hormonal changes in the vagina. It is being also for the prevention and treatment of osteoporosis.
Indication
Esterified estrogens are indicated to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. It is also indicated for the treatment of symptoms of breast cancer in both men and women. In men it can be used for the treatment of advanced prostate cancer. It is also indicated for the treatment of menopausal symptoms.
Associated Conditions
- Hypogonadism
- Metastatic Breast Cancer
- Premature Ovarian Failure (POF)
- Advanced carcinoma of the prostate
- Moderate Menopausal Vasomotor Symptoms
- Moderate Vulvovaginal atrophy
- Severe Vasomotor Symptoms Associated With Menopause
- Severe menopausal vulvovaginal atrophy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Syntho Pharmaceuticals, Inc. | 66576-284 | ORAL | 1.25 mg in 1 1 | 12/7/2022 | |
| ANI Pharmaceuticals, Inc. | 62559-149 | ORAL | 1.25 mg in 1 1 | 12/1/2017 | |
| Syntho Pharmaceuticals, Inc. | 66576-283 | ORAL | 0.625 mg in 1 1 | 12/7/2022 | |
| Bryant Ranch Prepack | 63629-1979 | ORAL | 1.25 mg in 1 1 | 12/1/2017 | |
| CENTRIX PHARMACEUTICAL, INC, | 11528-010 | ORAL | 1.25 mg in 1 1 | 1/25/2020 | |
| Amneal Pharmaceuticals of New York LLC | 53746-078 | ORAL | 1.25 mg in 1 1 | 12/31/2023 | |
| Bryant Ranch Prepack | 72162-1748 | ORAL | 0.625 mg in 1 1 | 8/29/2023 | |
| CENTRIX PHARMACEUTICAL, INC, | 11528-020 | ORAL | 0.625 mg in 1 1 | 1/25/2020 | |
| CREEKWOOD PHARMACEUTICAL, INC, | 15310-020 | ORAL | 0.625 mg in 1 1 | 1/22/2020 | |
| Bryant Ranch Prepack | 63629-9177 | ORAL | 1.25 mg in 1 1 | 4/26/2022 |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NEO ESTRONE TAB 1.25MG | neolab inc | 00287733 | Tablet - Oral | 1.25 MG | 12/31/1974 |
| ESTRAGYN | searchlight pharma inc | 00287725 | Tablet - Oral | 0.625 MG | 12/31/1974 |
| ESTRAGYN | searchlight pharma inc | 00473618 | Tablet - Oral | 0.3 MG | 12/31/1980 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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