US FDA Approves Five-Day Emergency Contraceptive

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First Published Friday, 13 August 2010 11:04 pm Р© 2010 Dow Jones

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday approved an emergency contraceptive pill that can be taken up to five days after unprotected sex.

The product, a prescription-only tablet, will be marketed in the U.S. by Watson Pharmaceuticals, Inc. (WPI). The company said the product will be sold as ella and will be available starting in the fourth quarter.

Ella is made by HRA Pharma, a closely-held Paris firm. Ella is designed to prevent pregnancy by inhibiting or delaying ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

In the U.S., a similar product called Plan B is sold over-the-counter and is designed to work if taken within 72 hours of a contraceptive failure or unprotected sex.

The FDA’s decision follows a unanimous advisory panel decision in June which said ella was safe and effective.

The FDA said drug side effects include headache, nausea, abdominal pain, pain or discomfort during menstruation, fatigue and dizziness.

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Always interesting to see women’s health in the business/stock sections of the news…….

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.