US FDA approves HRA Pharma's ella for prescription emergency contraception
The US Food and Drug Administration on Friday finally approved French company HRA Pharma's controversial emergency contraceptive product ella (ulipristal acetate), which received the thumbs up from an FDA advisory panel earlier this year, along with an outcry from the Family Research Council, which brands the drug as an abortifacient (The Pharma Letter June 18).
The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive. ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation.
Already sold in Europe and Asia, ella will be marketed by Watson in USA
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