FDA Approves Over-the-Counter Availability of Plan B One-Step® (levonorgestrel) for All Consumers

FDA Approves Over-the-Counter Availability of Plan B One-Step®(levonorgestrel) for All Consumers

-Plan B One-Step®will be the First Emergency Contraceptive to be in Store Aisles-

NORTH WALES, Pa.--(BUSINESS WIRE)-- Teva Women's Health, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYS: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the emergency contraceptive Plan B One-Step® (levonorgestrel) tablet 1.5 mg for over-the-counter sale to all consumers in the United States. This landmark decision represents the continuation of improving access to emergency contraception to all who need it, when they need it. Plan B One-Step® is the first one pill emergency contraceptive that will be available in store aisles with no age or point-of-sale restrictions, and will not require consumers to show identification in order to purchase it.

"Bringing Plan B One-Step® out from behind the pharmacy counter helps women tremendously by removing one of the biggest barriers to access and timely use of emergency contraception, which is critically important. Plan B One-Step® allows women to get what they need with one dose, without waiting 12 hours to take a second pill to complete the regimen," said Jill DeSimone, Senior Vice President & General Manager, Teva Global Women's Health. "We are committed to ensuring Plan B One-Step® is available to women who need it as it transitions into the aisle. As such, the price of Plan B One-Step® to wholesale and retail outlets will remain unchanged. 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."

"At Teva we are committed to ensuring information, educational tools and healthcare professional support are made available to all those who need it, right at the time that they need it," continued DeSimone. "These offerings make us a true partner for women as they manage their health through their reproductive years."

In the U.S., the unintended pregnancy rate remains high; nearly half (49%) of all pregnancies are unplanned. The fact that nearly half of the 3.1 million unintended pregnancies that occur in the U.S. each year occur in women who reported taking contraception during the month they conceived emphasizes the need for increased access to emergency contraception. With Plan B One-Step®,women can take an additional step to prevent an unintended pregnancy after contraceptive failure or unprotected sex.

"Teva, as well as women's health advocates and leading medical professionals, has worked for years to increase access to this time-sensitive product that is critically important to all women of reproductive age," said Martin Berndt, Vice President & General Manager, U.S. Brand Pharmaceuticals, Teva Women's Health, Inc. "As is customary for any prescription to full over-the-counter switch, and as requested by the FDA, Teva completed a clinical study to support non-prescription marketing of Plan B One-Step®. Teva is the only company that has conducted actual use and label comprehension studies required by the FDA, which show that women of all ages understand how to use Plan B One-Step®."

Consumers can learn more about Plan B One-Step® by visiting www.PlanBOneStep.com, where they can get reliable information about the product and when it should be taken, and review answers to frequently asked questions. There is also a toll-free hotline (1-800-330-1271) where consumers can talk live to a healthcare professional.

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. (NYS: TEVA) , 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, 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 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.

Plan B One-Step® is a registered trademark of Women's Capital Corporation, a subsidiary of Teva.

© 2013 Teva Women's Health, Inc.

Media Contact:
Teva Pharmaceutical Industries Ltd.
Denise Bradley, 215-591-8974

KEYWORDS:   United States  North America  Pennsylvania


The article FDA Approves Over-the-Counter Availability of Plan B One-Step® (levonorgestrel) for All Consumers originally appeared on Fool.com.

Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 - 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

Read Full Story