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FDA approves OTC Plan B for ages 15 and up

May 1, 2013 12:39 AM UTC

FDA approved an amended sNDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for Plan B One-Step levonorgestrel for use without a prescription by women ages 15 and older. The label for the emergency contraceptive, which was already approved for use in women ages 17 and older, states that proof of age is required for sale. FDA said data showed women 15 years and older "were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease." ...