Teva Pharmaceutical Industries, Ltd. announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Plan B One-Step emergency contraception (levonorgestrel tablet, 1.5 mg).
Now, with new Plan B One-Step, women can help prevent an unintended pregnancy after unprotected sex or contraceptive failure with just one pill in one dose. The FDA is expanding over-the-counter (OTC) access to Plan B One-Step for consumers age 17 or older; women younger than age 17 will require a prescription. The product will be available at licensed US retail pharmacies within the next month.
"As a leader in women's health, we're proud to offer women this new, innovative emergency contraceptive option that builds upon the trust that women have come to know with Plan B," notes Amy Niemann, general manager, senior vice president of Teva Women's Health. "Emergency contraception is more effective the sooner it's taken, and with Plan B One-Step women can now act quickly and take it right away when the unexpected happens."
Plan B One-Step will be available OTC at the pharmacy for consumers age 17 or older with government-issued proof-of-age identification. Women younger than age 17 will require a prescription to purchase Plan B One-Step.
When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B One-Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. Plan B One-Step should be taken as soon as possible after unprotected sex the sooner it is taken, the more effective it will be. Plan B One-Step will not work if a woman is already pregnant and it will not terminate an existing pregnancy.
Plan B One-Step is manufactured in partnership with Teva Pharmaceutical Industries, Ltd. by Gedeon Richter, Ltd. of Budapest, Hungary.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company.