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FDA Grants Plan B One Step Exclusivity on Drugstore Shelves

Update Date: Jul 24, 2013 10:26 AM EDT
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Teva Pharmaceuticals, the manufacturer of the emergency contraception morning after pill, Plan B One-Step will be able to sell its product on drugstore shelves without any age restrictions. Not only is Plan B One-Step now accessible for all people who need it, the U.S. Food and Drug Administration (FDA) announced late Monday night that it would grant Teva Pharmaceuticals the exclusive right to sell its contraceptive pill for three years. This means that for girls under 17 looking for an over-the-counter emergency contraceptive, their only option will be a hefty $50 dollar one until generic versions, which can be as low as $20 go on sale.

Plan B One-Step works to prevent unexpected pregnancies when it is taken within three days post intercourse. The drug is safe for women and girls who are sexually active. Since its introduction on the market, Plan B One-Step was sold behind pharmacy counters with age restrictions. Girls under 18-years-old were not allowed to purchase these drugs without a doctor's prescription. However, due to a recent ruling, Plan B One-Step and other emergency contraceptives can now be sold over the counter without any age restrictions. Even though this ruling marked a huge step for women's rights, the FDA has limited the progress by giving exclusivity to Teva Pharmaceuticals.

According to the FDA, generic versions of the one pill emergency contraceptive drugs will be on drugstore shelves as well. However, these versions can only be sold to women over the age of 17 without a prescription. For the two pill versions of the drug, they will remain behind the pharmacy counter and will only be sold to women over the age of 17 as well. These emergency contraceptive versions will be freely sold after August 2016.

"Companies seeing approval of generic versions of Plan B One Step or those who wish to continue marketing approved versions before Teva's exclusivity expires, must obtain approval of labeling that does not contain prescription labeling or impinge on Teva's exclusivity for non prescription use in women age 16 and below," the FDA stated.

By granting exclusivity, the FDA has limited sales of emergency contraceptives to a certain extent. Girls under the age of 17 will be forced to pay the more expensive fee for Plan B One-Step even though there are cheaper, generic versions.

For more information as to how Plan B One-Step become an over-the-counter drug, click on this Counsel & Heal article, Feds Drop Appeal: The Journey in Making Plan B Available for All Women

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