The FDA -- which in December 2011 rejected Teva Women's Health's application to make the so-called morning after pill available over-the-counter for all females of reproductive age -- said Tuesday it has approved an amended application filed by the company.
Dr. Margaret A. Hamburg, FDA commissioner, said the product will 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 a customer's age before selling the product. Teva has arranged to have a security tag placed on all product cartons to prevent theft, Hamburg said.
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.
It is a single-dose pill -- 1.5 mg tablet -- with the active ingredient levonorgestrel, which most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within three days after unprotected sex, the FDA said.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," Hamburg said in a statement. "The data reviewed by the agency demonstrated that women age 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."
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