MONDAY, Aug. 16 (HealthDay News) -- The ella emergency
contraceptive has been approved by the U.S. Food and Drug
Administration. It's been available in Europe for more than a year
under the brand name ellaOne.
To be taken within five days of contraceptive failure or
unprotected intercourse, the drug is not meant to be used as a
routine contraceptive, the FDA said in news release. Among a class
of drugs called progesterone agonists/antagonists, it's intended to
inhibit or delay ovulation.
Ella's safety and effectiveness were demonstrated in studies
conducted in the United States, United Kingdom and Ireland, the
agency said. The most common side effects included headache,
nausea, abdominal pain, menstrual pain, fatigue and dizziness.
Women with known or suspected pregnancy or those who are
breast-feeding shouldn't use ella, the FDA said.
The drug is distributed by Watson Pharma Inc., based in
Morristown, N.J.
More information
The FDA has more about
this approval.