For females aged 15 and older
WEDNESDAY, May 1, 2013 (HealthDay News) -- The Plan B "morning-after" emergency contraceptive pill has been approved by the U.S. Food and Drug Administration for distribution without a doctor's prescription to females aged 15 and older.
In 2011, the agency denied a petition filed by maker Teva Women's Health Inc. to approve the pill for all females of reproductive age. Teva then amended its FDA application to make the product available to females aged 15 and older.
The product will carry a label warning that proof of age will be required before sale. In addition, "Teva has arranged to have a security tag placed on all product cartons to prevent theft," the FDA said in a news release.
Plan B is designed to prevent pregnancy if taken within three days of unprotected sexual intercourse. It will not end pregnancy if a woman is already pregnant, and there is no evidence that if a pregnant woman does take the product that it will harm the developing fetus, the agency said.
The product also will not protect women from any sexually transmitted disease, the FDA warned.
Teva is based in North Wales, Pa.
To learn more about this product, visit the FDA (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm ).