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Limited Market Approval
Combined monthly injectable.
May 22, 2017
Active Pharmaceutical Ingredient (API):
Potential Multi-Purpose Technology (MPT):
single injection administered monthly
25 mg MPA, 5 mg estradiol cypionate
Sun Pharmaceuticals, India
PT. Tunggal Idaman Abdi
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.
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.
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