The U.S. Department of Justice will no longer try to appeal the ruling by a New York federal judge back in April that removed the age and point-of-sale restrictions for the emergency contraceptive Plan B One-Step (levonorgestrel; Teva). The FDA plans to approve the application for Plan B One-Step without age or point-of-sale restrictions as soon as it is filed by the manufacturer.
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Plan B One-Step is a single-dose (1.5mg tablet) emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse if another form of birth control (eg, condom) was not used or failed.
The two-pill version of Plan B along with other generic versions will still be restricted for younger girls due to a lack of safety data.
On May 1, 2013, the FDA approved an amended application to market Plan B One-Step for use without a prescription by women >15 years of age. However, this ruling was independent of the April litigation and was not intended to address the judge’s ruling.
For more information call (800) FDA-1088 or visit PlanBOneStep.com.