NORTH WALES, Pa.--(BUSINESS WIRE)--Teva Women’s Health, the U.S subsidiary of Teva Pharmaceuticals, today announced that the emergency contraceptive Plan B One-Step® (levonorgestrel) tablet 1.5 mg is now widely available in the aisles of major retailers nationwide with no age or point-of-sale restrictions. Plan B One-Step® is the first emergency contraceptive to be available for over-the-counter sale to all consumers.
“Since the U.S. Food and Drug Administration approved Plan B One-Step® with no age or point-of-sale restrictions on June 20, we have worked tirelessly to bring the product to market for all consumers as soon as possible,” said Martin Berndt, Vice President & General Manager, U.S. Brand Pharmaceuticals, Teva Women’s Health, Inc. “The availability of Plan B One-Step® in the aisles of retailers nationwide ensures improved access to a product that has been clinically evaluated and is a safe and effective back-up birth control method for women of all reproductive ages.”
Despite the many highly effective birth control options available, none are 100 percent effective at preventing pregnancy and inconsistent or incorrect use can more than double the failure rate of many birth control options. In fact, one survey found almost one-half of the women who used emergency contraception reported fear of birth control failure as a reason for use. With Plan B One-Step® available nationwide, women of all ages can be in control of their reproductive health by taking an additional step to prevent an unintended pregnancy after contraceptive failure or unprotected sex.
“Emergency contraception gives women a last chance to prevent pregnancy after birth control failure or unprotected sex,” said Jill DeSimone, Senior Vice President & General Manager, Teva Global Women's Health. “Women have faced challenges to obtaining emergency contraception for far too long, and the availability of Plan B One-Step® in the aisle for all consumers is a historic step forward.”
Teva is committed to ensuring Plan B One-Step® is available to all women who need it. As such, the price of Plan B One-Step® to wholesale and retail outlets will remain unchanged as it transitions over-the-counter. In addition to now being available in aisle, Plan B One-Step® will also continue to be sold to hospitals and health clinics at a subsidized price for women who may not otherwise be able to afford it.
“As a leader in women’s health, Teva is committed to supporting and empowering women by providing access to Plan B One-Step® when they need it,” continued DeSimone. “Teva remains committed to ongoing consumer education on Plan B One-Step® and will continue to work closely on education initiatives in partnership with healthcare professionals.”
Consumers can learn more about Plan B One-Step® by visiting www.PlanBOneStep.com, where they can get reliable information about what the product is and is not, when it should be taken, as well as review answers to frequently asked questions. Consumers can also speak live with a healthcare professional by calling a toll-free hotline (1-800-330-1271).
About Plan B One-Step®
Plan B One-Step® is a progestin-only emergency contraceptive that can help prevent pregnancy after birth control failure or unprotected sex. When taken within 72 hours (three days) after birth control failure or unprotected sex, Plan B One-Step® can help prevent a pregnancy from occurring in about seven of eight women who would have become pregnant otherwise. Plan B One-Step® is not an abortifacient and will not harm an existing pregnancy. Plan B One-Step® is a back-up method of preventing pregnancy, but it isn’t regular birth control and should not be used that way, as it is not as effective as regular birth control methods used correctly. For additional information, visit www.PlanBOneStep.com.
Plan B One-Step® (levonorgestrel) is intended to prevent pregnancy after known or suspected birth control failure or unprotected sex.
About Teva Women’s Health, Inc.
Teva Women’s Health, Inc. is a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd., headquartered in Israel. The company produces a wide range of women’s healthcare products including oral contraceptives, intrauterine contraception and hormone therapy treatments for menopause and perimenopause. Teva Women’s Health, Inc. maintains a strong commitment to enhancing women’s lives by actively pursuing new areas of research and providing distinct pharmaceutical options that meet women’s needs and fit their lifestyles. Through close engagement with women and healthcare providers, the company maintains an in-depth understanding of the important health matters that affect women.
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 develop and commercialize additional pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially COPAXONE® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.