Overview
Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy. In April 2023, the FDA withdrew its approval of Makena and its generics given an unfavorable risk-to-benefit assessment.
Indication
本品与戊酸雌二醇配伍作长效注射避孕药，具有排卵抑制作用，每月肌内注射一次，避孕效果肯定。
Associated Conditions
- Corpus Luteum Insufficiency
- Premature Births
- Primary Amenorrhoea
- Secondary Amenorrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/15 | Phase 4 | UNKNOWN | |||
2018/12/19 | Not Applicable | UNKNOWN | Aswan University Hospital | ||
2018/12/19 | Not Applicable | UNKNOWN | Aswan University Hospital | ||
2016/10/21 | Phase 1 | Completed | |||
2016/10/19 | Phase 3 | Terminated | |||
2006/12/11 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional LLC | 67457-886 | INTRAMUSCULAR | 250 mg in 1 mL | 11/15/2021 | |
| Amneal Pharmaceuticals of NY LLC | 69238-1797 | INTRAMUSCULAR | 250 mg in 1 mL | 8/1/2018 | |
| AuroMedics Pharma LLC | 55150-311 | INTRAMUSCULAR | 1250 mg in 5 mL | 6/22/2022 | |
| American Regent, Inc. | 0517-1767 | INTRAMUSCULAR | 250 mg in 1 mL | 7/1/2018 | |
| Sun Pharmaceutical Industries, Inc. | 47335-037 | INTRAMUSCULAR | 250 mg in 1 mL | 4/18/2019 |
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 |
|---|---|---|---|---|---|
| PROLUTON DEPOT INJECTION 250MG/ML | SIN14879P | INJECTION | 0.250g/ml | 10/27/2015 |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.