The FDA announced that it has approved an amended application to market Teva’s Plan B One-Step (levonorgestrel) for use without a prescription by women >15 years of age. Teva submitted an amended application to the FDA after the agency decided not to approve the December 2011 application to make Plan B One-Step available OTC for all females of reproductive age.
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.” The product 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 cartons to prevent theft. Teva will also make the product available in retail outlets with an onsite pharmacy during the store’s normal operating hours whether the pharmacy is open or not.
This approval was based on actual use study and label comprehension data showing that women age >15 years understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. Data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider.
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 years of age 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.
There are currently three emergency contraceptive drugs marketed in the U.S. – Plan B One-Step, Plan B, and ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (0.75mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal; Actavis) 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.
Plan B One-Step is a single-dose (1.5mg tablet) emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse if another form of birth control (eg, condom) was not used or failed.
For more information visit the FDA website.