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Plan B Approved for Women 15 Years and Older Without Rx

FDA says company submitted data showing that women 15 years and older understood proper use

WEDNESDAY, May 1 (HealthDay News) -- The U.S. Food and Drug Administration has approved Plan B One-Step emergency contraceptive for over-the-counter sales to women 15 years of age and older.

The approved application is based on an actual use study and label comprehension data submitted by the drug's manufacturer Teva Women's Health 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. These data also demonstrated that, for this age group, Plan B One-Step could be used properly without the intervention of a health care provider.

Plan B One-Step, a single-dose pill (1.5 mg levonorgestrel tablet) taken within three days of unprotected sexual intercourse to decrease the possibility of unwanted pregnancy, will be available on the shelves in retail outlets with an onsite pharmacy, generally in the family planning or female health aisles. The FDA says 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." Teva has said it is willing to conduct an audit of the age verification practices to ensure that the age limitation is being followed. Additionally, to prevent theft, Teva has arranged to have a security tag placed on all product cartons.

"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," Margaret A. Hamburg, M.D., Commissioner of the FDA, said in a statement.

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