(HealthNewsDigest.com) - North Wales, PA — Teva Pharmaceuticals, Inc. (NASDAQ: TEVA) announced today 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.
“With Plan B® One-Step, emergency contraception is now available in just one pill that can be taken right away when the unexpected happens,†notes Amy Niemann, General Manager, Senior Vice President of Teva 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®.â€
“I prefer one-pill dosing for my patients because it allows them to act more quickly, while providing a high level of safety and efficacy,†comments Ashlesha Patel, MD, MPH, Division Director of Family Planning Services, John H. Stroger, Jr., Hospital of Cook County in Chicago. “Emergency contraception is more effective the sooner it’s taken, and Plan B® One-Step provides a back-up plan that’s just one pill away.â€
“Plan B® One-Step is an exciting milestone in women’s reproductive health, and I applaud Teva for continuing to develop products that empower women,†says Kelli Conlin, President of the National Institute for Reproductive Health. “Healthcare providers and women’s advocates have been eager for a one-pill emergency contraceptive for years and are happy to see it finally come to fruition.â€
About Plan B® One-Step
Plan B® One-Step (www.PlanBOneStep.com) 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.
Consumers Are “In the Knowâ€â€¦And Pharmacists Are, Too
Awareness of Plan B® has increased significantly since OTC approval in 2006. Today, more than 88 percent of 18-to-30-year-olds categorize Plan B® as emergency contraception, up from 64 percent in 2006. Among those familiar with Plan B®, there is high awareness of what it is, where to get it, and how to use it. Eighty-six percent of individuals understand that the product prevents rather than terminates pregnancy and that it is NOT RU-486.
Additionally, U.S. retail pharmacists are overwhelmingly compliant with dispensing guidelines. In fact, just one year after OTC approval, 99 percent of pharmacists who sold Plan B® were aware of its dual-label status and 95 percent were comfortable selling/dispensing Plan B®.
About Teva
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. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
Important Safety Information
PLAN B® ONE-STEP IS INTENDED TO PREVENT PREGNANCY AFTER KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE OR UNPROTECTED INTERCOURSE.
Plan B® One-Step isn’t effective if you’re already pregnant, and it won’t terminate an existing pregnancy. Plan B® One-Step doesn’t protect against HIV and other sexually transmitted diseases (STDs). Side effects may include changes in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness. If your period is more than a week late, you may be pregnant. If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical help. Please see full product information enclosed. Important product information is also available on www.PlanBOneStep.com, by calling 1-800-330-1271, or by speaking to your pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA at fda.gov/medwatch or call 1-800-FDA-1088.
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