The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases.
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“The data reviewed by the agency demonstrated that women 15 years of age 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.”
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.
Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse. Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse – if another form of birth control (e.g., condom) was not used or failed. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not. In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles.
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The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.Īfter the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc.
Plan B One-Step Emergency Contraceptive FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
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