FDA Approves Plan B(R) One-Step, A New One-Pill Emergency Contraceptive

Main Category: Pregnancy / Obstetrics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Jul 2009 - 5:00 PDT

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Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced that the U.S. 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 U.S. 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."

About Plan B® One-Step

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.

Source
Teva Pharmaceutical Industries Ltd

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