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Cyclofem
Product Overview
Development Status:
Limited Market Approval
Target:
Female
Mode:
Hormonal
Delivery Type:
Injectable
Duration Type:
Short-acting
Description:
Combined monthly injectable.
Updated date:
May 30, 2018
Vertical Tabs
Product Details
Active Pharmaceutical Ingredient (API):
medroxyprogesterone acetate
,
estradiol cypionate
Potential Multi-Purpose Technology (MPT):
No
Regimen:
single injection administered monthly
Duration:
monthly
Dose:
25 mg MPA, 5 mg estradiol cypionate
Partner:
Concept Foundation
,
Sun Pharmaceuticals, India
,
WHO HRP
,
PT. Tunggal Idaman Abdi
Status
Project Phase:
Post-development
Project Stage:
Marketed
Status Details:
CycloFem is registered and in use in Indonesia and a few countries in Latin America. Concept Foundation has the commercial rights. CONRAD has conducted PK studies on CycloFem to support the US FDA approval process.
The same formulation was previously approved in the US as Lunelle (in 2000), marketed by Pfizer, but was removed from the market because of production problems.
Programmatic Considerations
Considerations:
Combined injectables are thought to provide better cycle control than progestin-only injectables (i.e., more regular bleeding patterns).
Well accepted in countries it is currently used. Provides option for women who desire regular menses for cultural / personal reasons.
Additional Information
Download Product Report
