FDA Approves Single-Dose Plan B Emergency Contraceptive

The US Food and Drug Administration has approved a single-pill version of the Plan B emergency contraceptive, which is currently available as a two-pill dose. Teva Pharmaceutical Industries Ltd announced yesterday (see PDF) that the new version, Plan B One-Step, will be available by the end of August.

Emergency contraception (EC), also known as Plan B, is effective up to five days (120 hours) after unprotected sex, birth control failure, or rape, but it is most effective (95 percent) if taken within 24 hours. Because of the time-sensitive nature of EC, over-the-counter access is crucial to its effective use. Plan B does not terminate an existing pregnancy.

Kelli Conlin, president of the National Institute for Reproductive Health, applauded the release of Plan B One-Step. “It is critical that women have fast, easy access to this back up method of birth control. I applaud Plan B for continuing their commitment to women’s reproductive health,” she said in a press release.

The FDA also announced earlier this year that it will not appeal a court order directing the FDA to make emergency contraception available over-the-counter to women as young as 17. Edward Korman, a New York District Court Judge, ruled in March that the FDA must reconsider its 2006 ruling that allowed emergency contraception, also known as Plan B, to be sold without a prescription to women 18 and older. Women younger than 17 years old will still need a prescription to receive Plan B.


Teva Pharmaceuticals Press Release 7/13/09; National Institute for Reproductive Health Press Release 7/13/09; Feminist Daily Newswire 3/24/09, 4/23/09

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