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|April 30, 2013 6:49 p.m.|
|FDA Approves Over-The-Counter Availability of Plan B One-Step® (levonorgestrel) tablet 1.5 mg for Consumers 15 and Over|
“For the past decade, emergency contraception has been available to millions of women to reduce the chance of an unplanned pregnancy following birth control failure or unprotected sex,” said
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified”. Age verification continues to be an important requirement with emergency contraception products. Similar to the processes that have been in place since the original prescription to over-the-counter switch of Plan B® (levonorgestrel) tablets in 2006, strict age verification procedures will be followed at retail. The measures that will be implemented to ensure the appropriate sale of Plan B One-Step® follows the procedures that are in place for the control of the sale of nicotine-containing products at retail. These measures include a UPC code that when scanned by a cashier will trigger an automatic message, prompting them to request proof of age from the customer and to verify age. If age-verification cannot be performed, or if the intended customer does not meet the age requirement, the sale cannot proceed. In addition to these measures at the point-of-sale, all product cartons will include a security tag as well as a hard plastic shell design for added security to reduce the possibility of theft.
Why Access Matters
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.
Plan B One-Step® can be used up to 72 hours following birth control failure or unprotected sex to help decrease the chance of becoming pregnant; however, the sooner it is taken, the better it works. Plan B One-Step® is not an abortifacient and will not harm an existing pregnancy.
“This decision allows stores to place Plan B One-Step® directly on store shelves, so that women have immediate access to emergency contraception when they need it most to help reduce their chance of unintended pregnancy,” said
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® is a registered trademark of Women’s
© 2013 Teva Women’s
Plan B One-Step® (levonorgestrel) is intended to prevent pregnancy after known or suspected birth control failure or unprotected sex.
About Teva Women’s
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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