Sometimes morning after pill is required for unprotected sex to avoid unplanned pregnancy.
FDA OKs new "morning-after" pill
WASHINGTON (Reuters) - Health officials on Friday approved a new, longer-lasting "morning-after" pill to prevent pregnancy after unprotected sex.
The prescription drug, called ella, is made by French company HRA Pharma and will be sold in the United States by Watson Pharmaceuticals.
The drug will compete with Teva Pharmaceutical Industries Ltd's Plan B, which works for up to three days after intercourse. Plan B is available without a prescription for those aged 17 and older, but ella will require a prescription for all ages.
The Food and Drug Administration said it cleared ella based on two clinical trials that showed the drug was safe and effective. The drug "is not intended for routine use as a contraceptive," the FDA said in a statement.
"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.
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