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The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.
Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:
Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to OTC use. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package.
The agency remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.
For more information on Plan B and today's action, please see: http://www.fda.gov/cder/drug/infopage/planB/default.htm.
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