SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy.
Teva has indicated that it plans to educate consumers, pharmacy staff, and healthcare professionals about the product’s new status. It has also indicated its willingness to conduct an audit of the age verification practices after the product is approved to ensure that the age limitation is being followed.
After 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.
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.
In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
On April 5, 2013, a federal judge in New York ordered the FDA to grant a 2001 citizen’s petition to the agency that sought to allow over-the-counter access to Plan B (a two dose levonorgestrel product) for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions. However, Teva’s application to market Plan B One-Step for women 15 and older was pending with the agency prior to the ruling.
The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling.
The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.
There are currently three emergency contraceptive drugs marketed in the United States — Plan B One-Step, Plan B, and Ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (.75 mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal) is a prescription-only product that prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected sexual intercourse. The approval of Teva’s application for Plan B One-Step does not affect the prescription status of these other drugs, the agency noted.
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