Plan B Contraceptive Approved for All Females of Childbearing Age
Thursday's agency announcement followed an April ruling by the U.S. District Court in New York that the product had to be made available without restriction, including age.
Plan B is meant to reduce the chances of pregnancy if taken within 72 hours of unprotected sex or suspected contraceptive failure. The product was first approved in 2009 as an over-the-counter option for women 17 and older, and as a prescription option for younger females.
The product will not end the pregnancy of a female who is already pregnant, and there is no evidence that it will harm a developing fetus, the FDA said in a news release. It will not prevent any sexually transmitted disease, including HIV/AIDS, the agency added.
Some females who have taken Plan B have reported these side effects: nausea, vomiting, stomach pain, headache, dizziness and breast tenderness. These adverse reactions are similar to those reported after use of other birth control products, the FDA said.
Plan B is produced by Teva Women's Health, a unit of the Israeli drug maker Teva Pharmaceutical Industries.
More information
The FDA has more about this approval.
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