FDA Approves Over-The-Counter Availability of Plan B One-Step® (levonorgestrel) tablet 1.5 mg for Consumers 15 and Over
01 Mai 2013 - 12:49AM
Business Wire
Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva
Pharmaceutical Industries Ltd. (NYSE: 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 consumers 15 years of age and
older in the United States. This decision marks the continuation of
improving access to emergency contraception for women and is the
first time that an emergency contraceptive will be available in the
store aisle. Plan B One-Step® will now transition from behind the
pharmacy counter to retail outlets with an onsite pharmacy, where
it generally, will be available in the family planning or female
health aisles. The product will be available for sale during the
retailer’s normal operating hours whether the pharmacy is open or
not.
“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 Marty
Berndt, Vice President & General Manager, U.S. Brand
Pharmaceuticals, Teva Women’s Health, Inc. “Today, we welcome the
FDA’s decision to provide extended and improved access to this
important product, a significant milestone for women.”
Age Verification
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 Ashlesha A. Patel, M.D., M.P.H., System
Director of Family Planning Services of Cook County Health &
Hospitals System (CCHHS) and Associate Professor and Assistant
Medical Student Clerkship Director of Feinberg School of Medicine
at Northwestern University in Chicago. “Providing easier access to
emergency contraception will allow women greater control over their
reproductive health and family planning goals.”
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 Capital
Corporation.
© 2013 Teva Women’s Health, Inc.
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. (NYSE: 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, including
that relating to the generic version of Protonix®, 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.
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