FDA Approves Plan B One-Step
FDA Approves Plan B One-Step, a New One-Pill Emergency Contraceptive
Single-dose Formulation Can Be Taken Right Away
NORTH WALES, Pa., Jul 13, 2009 - Teva Pharmaceuticals, Inc. 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."
"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."
"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."
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.
Consumers Are "In the Know" 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.
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.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin ®, Lotrel®, Protonix® and Ortho Tri-Cyclen Lo®, the current economic conditions, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the effects of competition on our innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals, Inc., the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
Plan B One-Step is a registered trademark of Women's Capital Corporation, a subsidiary of Duramed Pharmaceuticals, Inc.
Posted: July 2009
- FDA Approves Plan B One-Step Emergency Contraceptive For Use Without A Prescription For All Women Of Child-Bearing Potential - June 20, 2013
- FDA Approves Plan B One-Step Emergency Contraceptive Without a Prescription for Women 15 Years of Age and Older - April 30, 2013