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FDA approves new emergency contraception

On Friday, August 13, 2010, the Food and Drug Administration approved a new prescription only emergency contraception called ella™. ella™ has been available in Europe by prescription since May 2009 under the name of ellaOne.

ella™ is a progesterone agonist/antagonist whose main effect is to inhibit or delay ovulation. It can prevent pregnancy if taken within 120 hours (5 days) after a contraceptive failure or unprotected intercourse. It is not intended to be used as regular contraception.

The safety and efficacy of ella™ has been demonstrated in two Phase III trials conducted in the United States, the United Kingdom, and in Ireland. The FDA Advisory Committee for Reproductive Health Drugs discussed ella™ in June 2010 and unanimously voted that the application provided sufficient data on the safety and efficacy of the drug for the purpose of emergency contraception.

Some the side effects recorded in the clinical trials are: headache, nausea, abdominal pain, and dizziness. The side effects for ella™ are similar to the side effects for the already FDA-approved Plan B emergency contraceptive.

For full labeling information visit the FDA website. For more information about ella, visit the HRA Pharma website.




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