The prescription drug, called Ella, is made by French company HRA Pharma and will be sold in the United States by Watson Pharmaceuticals. Known chemically as ulipristal, the drug already is sold in several European countries under the name ellaOne. HRA Pharma has said it has also begun seeking approval in other countries.
It is the first emergency contraceptive approved since a five-year battle under the Bush administration ended with limited over-the-counter sales and age checks by pharmacists for a rival pill.
Ella has been shown to prevent pregnancy for up to five days after unprotected sex.
Women's groups, Democrats and other advocates say the pills offer women much-needed options to plan their families and provide a safety net when other birth control methods fail or women are raped.
"Every woman deserves every option available to prevent an unplanned pregnancy, and there are many reasons why a woman may face the risk of unintended pregnancy -- from failure or improper use of birth control, to sexual assault," Cecile Richards, president of Planned Parenthood Federation of America, said in a statement.
Ella is a type of selective progesterone receptor modulator, making it part of a class of drugs that interfere with the hormone progesterone that is crucial for pregnancy. The class also includes the abortion pill known as RU-486, or mifepristone, and sold as Danco Laboratories' Mifeprex.
Watson said the overall pregnancy rate for women who took Ella within three days of sex was 1.9 percent, lower than the anticipated rate of 5.6 percent. For women who took the drug two days to five days after sex, the pregnancy rate was 2.2 percent, lower than an expected rate of 5.5 percent.
Company officials and the FDA have said Ella appears to work primarily by preventing the release of a woman's egg for up to five days after unprotected sex, although the lining of the uterus is also affected.
Side effects of Ella
-similar to those of Plan B, include headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The drug should not be taken by women who are pregnant or nursing.
The two emergency contraceptives work differently:
- Plan B contains levonorgestrel, a progestin hormone used in lower doses in many birth control pills.
- Ella contains ulipristal, a non-hormonal drug that blocks the effects of key hormones necessary for conception.
- Plan B should be taken as soon as possible after sex. It may work for up to 72 hours, but is ineffective once insemination triggers the hormonal surge that leads to ovulation.
- While emergency contraception should not be delayed, Ella's effectiveness does not fade for 120 hours (five days) after sex, regardless of whether the hormonal surge has occurred.